Psc Biotech Jobs

Miracle Point is a dynamic and forward-thinking medical device startup incubator that provides one-stop solutions to develop ideas and accelerate new product launches. We are looking for energetic candidates interested in working with an entrepreneurial ethos. Established from MicroPort 's experience in building businesses, Miracle Point is focused on nurturing ideas and products that include devices for coronary interventions, respiratory support, women's health monitoring, and many more. We leverage our decades of experience with product launches around the globe to provide support ideation and commercialization. We have had success supporting initiatives from initial conceptualization to successful commercial launch and finally public market capitalization or acquisition. Currently we are looking for an Executive/Operations Assistant to assist in various parts of the business including support to help expand the Miracle Point footprint within the United States. The individual in this role will be a problem-solver, and need to coordinate between various cultures and teams around the world including those located in Shanghai, Hong Kong, the European Union, and the United States. These may include short-term solutions in scheduling conflicts and more complex issues as they arise. The candidate should have an aptitude for timely and efficient task execution. The candidate will have unique opportunities and exposure to large corporate strategy while also operating in a small business environment and culture. Job Responsibilities: Provide primary support to executive leadership and assist the executive team members, as directed, helping to track progress on company goals and objectives while ensuring administrative goals are met. Represent the executive leader in day-to-day operations and executive administrative tasks Working directly with the Executive Leader: Undertake and implement strategic instructions, Assist in promoting & implementing company initiatives, Efficiently communicate and coordinate across the team to ensure alignment on strategic goals. Coordinate and promote the implementation of key decisions and report the results of the operation overview to the CEO in a timely manner. Collect, review, and analyze data and prepare reports, charts, budgets, and other presentation materials utilizing word processing, spreadsheet, LLM/AI platforms Draft and proofread documents, presentations, and reports as needed. Maintain professionalism and strict confidentiality with all materials. Manage professional and personal scheduling for the executive leader, including agendas, mail, email, phone calls, client management, and other company logistics. Schedule and coordinate travel, and other (group) activities as needed. Manage expense reporting (receipt management) & invoicing. Provides general administrative/office support (clerical, maintaining office supplies, etc.). Provide general support to visitors. Perform other related duties as assigned. Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of all responsibilities, skills, duties or requirements associated with the job. Job Requirements: Requires a bachelor's degree. 4+ years of working experience in a similar role, reporting directly to executive management. Experience in a start-up or consulting environment is a plus. Experience in developing internal processes and filing systems. Excellent communication skills (verbal & business emails). Experience utilizing AI or LLM models to supplement work efficiency Strong ability to organize, multitask, prioritize, and work under pressure. A quick learner. Ability to work independently & collaboratively, to prioritize tasks and to meet deadlines. Ability to coordinate complex travel arrangements for multiple people. Mandarin or other foreign language skills (Japanese, German, French, Italian) speaking a plus. Prolonged periods sitting at a desk and working on a computer. Must be able to lift 25 pounds at times. Perks: We offer competitive pay, as well as excellent benefits options including medical, dental, & vision, and individual supplemental insurance options. Additionally, we offer a 401K plan with employer matching, paid holidays and a PTO policy. About MicroPort : MicroPort was founded in Shanghai, China in 1998 when a group of dedicated individuals joined together by the common belief that advancements in medical technology could transform patients' lives. Over the last two decades, MicroPort has expanded around the globe and taken important steps towards fulfilling its mission of providing trustworthy and universal access to state-of-the-art solutions of prolonging and reshaping all lives. MicroPort was listed on the main board of Hong Kong Stock Exchange in 2010. To learn more, please visit our website: ********************** and **********************reshaping-health/driving-innovation MicroPort and its subsidiaries are proud to provide equal-opportunity employment to all employees and applicants, without regard to race, creed, color, religion, national origin, citizenship, ancestry, age, veteran status, disability, pregnancy, marital status, genetic information, or any other categories protected by federal, state, or local law. As per company policy, official hiring will be pending the results of a background check and drug test.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. GLOBAL COMMERCIAL AND CORPORATE FUNCTIONS:BioMarin's Commercial team encompasses a diverse group of functions across the globe including Field Sales, Patient Support Teams, Market Access, Brand Management, and Operations. BioMarin has recently moved to a “product-Centric”/matrix model where Business Units roll up to the Chief Commercial Officer and have P&L responsibilities for the BioMarin therapies. The Global Commercial function encompasses teams across the globe.Biomarin's Corporate Functions are responsible for various aspects of the company's operations to include Finance (FP&A, Accounting, Treasury, Internal Audit), Legal & Compliance, Corporate Communications, People (HR), and Sourcing & Procurement -- the areas of the business that provide the foundation to enable BioMarin to develop and deliver novel therapies to treat patient needs.JOB SUMMARY:Are you ready to take on a pivotal role in shaping the future of healthcare technology at a leading biotechnology company? The CIO is searching for a visionary leader to join our dynamic team as the Head of Customer Facing IT - Global Commercial and Corporate Functions. This is not just a job; it's an opportunity to make a profound impact on the lives of patients worldwide by driving innovative IT solutions that support life-changing therapies. This person who is part of the IT Leadership team is a dynamic, business savvy, IT leader who can drive the business enabling technology strategies aligned with the strategic imperatives of the Commercial and Corporate groups.This role will support all commercialized and launching brands across our markets. Additionally, this role will support the Corporate groups to design and deliver cohesive strategies that align technology efforts with the company's goals and objectives. This includes setting technology strategy, establishing governance frameworks, and ensuring compliance with regulations.Deep business understanding of the Commercial and Corporate domains is the most important aspect of this role. The ideal candidate will have a broad understanding of the Commercial and Corporate spaces in a life science company and a commitment to driving top-line growth through innovation and value creation.This role will drive the strategic use of technology, data capabilities, and business process improvements to support business growth and successfully enable the patient and health care practitioner journey. They will serve as a strategic partner and trusted advisor to Commercial and Corporate teams globally, designing and leading a Commercial and Corporate technology strategy aligned with business leadership.This role will also participate in technology oversight activities along with the Enterprise Architecture and Strategic Platforms teams within IT to align tech solutions for Commercial and Corporate areas and prioritize the portfolio of technology projects.KEY EXPECTATIONS: Strategic Leadership: Partner with Commercial leadership to develop and implement the IT strategy aligned with overall business objectives that deliver transformative therapies to our patients within the Skeletal Conditions, Enzyme Replacement, and ROCTAVIAN Business Units. Partner with Corporate Leadership to include senior leaders that represent Strategy, Legal & Compliance, People (HR), Corporate Affairs, and the Finance groups. Partner with the other Head of Customer Facing IT (R&D & Technical Operations) to build a cohesive technology strategy and portfolio for the company. Lead the technology aspects of digital transformation initiatives to enhance omnichannel capabilities and our customer experience. Collaborate with senior leadership to identify and prioritize technology projects which drive business growth, innovation, and value creation. Understand commonality between Business Units and strive to standardize technology solutions to deliver high impact products for the Commercial area to drive top line growth. Build, champion and support an analytical platform that will allow us to understand customer behavior and preferences, driving personalized and targeted marketing efforts. Partner with Tech Foundations and Cyber to leverage enterprise platform strategy, build a culture of Cyber Security and maintain a safe fabric of enterprise data. Commercial and Corporate IT Management: “Run IT-as-a-Business”-have a P&L mindset when managing budget or determining discretionary project investments to drive maximum value. Lead a team of Commercial and Corporate Customer Facing IT (CFIT) tech partners and delivery experts by providing guidance, mentorship, and performance management. Leverage a DevOps team to support the effective integration of IT systems with Commercial Operations, including sales, marketing, Medical Affairs, and supply chain. Implement and manage technology solutions that support multi-channel operations, including CRM, and customer service tools. Manage the IT budget for the Commercial & Corporate CFIT organization to maintain financial targets and find/make tradeoffs as needed to meet potential changes in customer demand. Be an advocate of cyber security for Commercial and Corporate personnel. Prioritize and deliver results with a high emphasis on quality, technical rigor and detail. Innovation: Constantly monitor industry trends and emerging technologies, identifying opportunities for innovation and growth specific to the Commercial and Corporate areas. Drive the adoption of best practices and new technologies including Ai capabilities. Have zeal towards delighting customers through delivering high quality solutions. Growth Mindset: Partner with key stakeholders and Business Units to determine the most effective ways to use technology to drive top-line growth. Leverage platform centric approach and key vendors to allow for faster implementation of technology solutions. Value Commitment: Form trusting, collaborative and strategic relationships with internal stakeholders and external partners with skills in assertion, negotiation, influencing, tact and diplomacy. Communicate IT strategies, initiatives, and performance metrics to senior leadership and other stakeholders. Collaborate with cross-functional teams to ensure alignment and integration of IT initiatives with business goals. Communications/Personal Interactions: Ability to think strategically and demonstrate data-driven decision-making. Proven track record of interacting with Senior Executive Stakeholders. Excellent leadership, communication, and stakeholder management skills. Ability to communicate complex information simply and effectively. Foster a culture that is constantly improving quality and creating efficiencies. QUALIFICATIONS: Proven experience in the Commercial and Corporate spaces (IT or Business) with a passion for leveraging technology to achieve company objectives. Experience across a broad range of Commercial and Corporate Operations functions. Minimum BS/BA or greater related to computer science, business administration. Minimum of 10-years of experience managing multi-disciplinary global team. Minimum of 10-years of experience in project delivery or portfolio management. Demonstrated experience building, leading, and nurturing high performing teams particularly through change. Experience with Agile development methodologies preferred. Biotech, Pharmaceutical or healthcare industry experience is required. LEVERAGE/UNDERSTAND STRATEGIC PLATFORMS (examples): Data analytics and customer insights tools Omnichannel marketing platforms Salesforce.com CRM (SFDC) Ai and GenAi tools and platforms Power BI Marketing Automation Platforms (Marketo, SFMC) Veeva Platform Sales Enablement Tools SAP WORK ENVIRONMENT/PHYSICAL DEMANDS: The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $212,000 to $318,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered. #J-18808-Ljbffr

We advance science so that we all have more time with the people we love. The Modeling and Simulation group within the Translational PKPD Department at Genentech, Inc. is seeking a PKPD/QSP Modeling & Simulation Scientist who is driven to enhance drug development through quantitative modeling and simulation of PKPD and biological systems. Our group supports projects in various stages of research and development across a range of therapeutic areas and molecule types/formats. We comprise scientists with PhDs in computational disciplines with expertise in mechanistic biological modeling and simulation, data-driven modeling, bioinformatics and systems biology, computational algorithm and tool development, and translating complex biology into quantitative models. We work closely with collaborators across all disciplines in therapeutic areas such as oncology and cancer immunotherapy, immune and inflammatory disorders, ocular disease, neurological disorders, and more. Efficient communication and collaboration with biological and clinical collaborators are critical skills. Opportunity: As an integral member of this dynamic team, you will be: Develop and apply mechanistic PKPD and systems pharmacology models in various therapeutic areas including oncology, immune & inflammatory disease, and other disease areas to support our drug development pipeline. Independently strategize, plan, execute, and report QSP and PKPD modeling activities, as well as to present work at cross-functional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences. Work in close partnership with other scientists in Modeling and Simulation, Clinical Pharmacology, Clinical Science, Informatics, Biostatistics, Preclinical and Translational PK, DMPK, Safety Assessment, Biomarker, Diagnostics, Regulatory, and other functions. Contribute to best practices on application of QSP and mechanistic PKPD in drug development. Present results at cross-functional teams, department meetings, review committees, and conferences. Adapt and thrive in an interactive, team-oriented culture. Who You Are: Ph.D in: chemical, biomedical, or other relevant engineering fields, pharmaceutical sciences, or a related discipline. Typical post-PhD experience requirements are roughly: Senior Scientist, 0-3 years; Principal Scientist, 3-7 years. Proficiency with PKPD and biological systems modeling approaches such as differential equations, logic, stochastic, agent-based, and/or other advanced mechanistic modeling approaches is essential as is proficiency with appropriate programming language and software (e.g., MATLAB/Simbiology, R, Python). Excellent communication and interpersonal skills and the ability to work independently and effectively on cross-functional teams; Strong leadership skills and the ability to influence project team collaborators. Strong track record of external scientific presentation and publication, commensurate with hiring level. Relocation benefits are available for this posting. The expected salary range for this position based on the primary location of California is $101,500-$232,900 (Senior Scientist) and $148,200-$275,200 (Principal Scientist). Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. #J-18808-Ljbffr

About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Manufacturing Shift Lead SUMMARY BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. RESPONSIBILITIES * Leadership * Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight * Accomplishes tasks through direct and effective coordination * Provides direction and hands-on training for staff * Supports the management of staff with supervisor * Lives department values and sets the standards for others to operate * Fosters an environment of compliance, strong work ethic and ongoing learning * Contribution * Ability to take responsibility for moderate level projects * Effective interaction with peer Leads across manufacturing to create alignment and improvement * Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities * Process Knowledge * Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance * Ability to troubleshoot, identify issues and support resolutions with technical groups * Required to perform ongoing operational tasks in respective work area * Uses scientific thinking and decision making in daily work * Technical Competency * Proven experience with relevant process, theory and equipment * Experience with process automation and functionality * Assist with review and approval of documentation including Batch Records and logbooks * Support the closure of Manufacturing owned Quality Records (deviations, change requests) * Other duties as assigned EXPERIENCE Required Skills: 2-4 years Manufacturing Experience 0-2 years Leading a team Familiarity with manufacturing softwares, Chrome skids, TFF skids Delegating work, leading a team, following production schedule Desired Skills: 2-4 years Manufacturing Experience 0-2 years Leading a team Desired skills is experience with Oracle, MES, Microsoft Teams, communication with groups EDUCATION BA/BS desired not required, 1-2 years leading Manufacturing experience EQUIPMENT Chrome Skids, TFF skids, buffer tanks, labwashers, autoclaves CONTACTS Will interact with manufacturing, automation, facilities, instrumentation, QA, QC SHIFT DETAILS This position is for the Back half Day shift Wed/Thurs-Sat 6am-7pm ONSITE, REMOTE, OR FLEXIBLE Onsite only TRAVEL REQUIRED None Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $ 68,300 to $ 102,500 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Corporate Groups It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin. BioMarin Internal Audit is committed to helping BioMarin achieve its full potential in transforming patient's lives by minimizing overall company risk. We pride ourselves in being objective and independent of the areas we assess, while maintaining our commitment to advance the organization. We provide independent assurance to the board of directors and management. Our disciplined approach evaluates the effectiveness of BioMarin's risk management, control and governance processes. We also assist with proactive advisory projects. An open and transparent partnership helps us develop the appropriate context and understanding of the issues at hand, minimize surprises, and drive greater value in the outcomes.In carrying out our mission, we pledge to: Be a trusted partner Lead with integrity & enthusiasm Focus on what matters Share industry practices As part of our mission, we also aim to provide valuable business insights (covering governance, risk, and control, and beyond), and we are building an audit data analytics platform to support in pro-actively identifying potential indicators for non-compliance, fraud and waste. Sr. Associate, Internal Audit: This role supports the Head of Internal Audit, and the Sr. Associate will be instrumental in building a world-class internal audit function, a function that provides both assurance and advisory services regarding BioMarin's governance, risk and control effectiveness, as well as a function that generates actionable business insights. This role partners with other members of the Internal Audit team and is responsible for performing audits to evaluate the design and effectiveness of internal controls, to identify instances of non-compliance, ineffective or inefficient operations, potential fraud, waste, and abuse. In carrying out this role, you must demonstrate good business acumen and robust experience with assessing risk and conducting internal audits. You serve as a trusted partner to the business, continually staying abreast of enterprise-wide initiatives and functional strategies, to ultimately ensure that the Internal Audit portfolio of audits is aligned with key business risks. Responsibilities The position of Sr. Associate reports to the Head of Internal Audit. The major responsibility of this position is business partnering, developing business acumen, data analysis, execution, reporting audit results, as well as strengthening relationships with the business stakeholders. 1. Planning the audit Development of scope and objectives of various audits Conduct relevant data analytics to support planning, scoping Meet with relevant stakeholders to understand risks and priorities of the audit Coordinate with external subject matter experts, as appropriate 2. Conducting the Audit Ensure the audit is executed with high quality, including work performed by third party subject matter resources Perform quality self-review for accuracy, clarity, completeness, and adherence to program and audit techniques employed Escalate any critical audit issues appropriate management 3. Reporting Results Communicate issues and root causes with management of the area under audit and gain consensus on the path forward Collaborate with management to develop risk-based response and action plan; this will often include facilitating a strategic assessment of options and costs-benefits Be able to fully evaluate risks and exposures and risk-rank issues accordingly Develop high quality deliverable, including sophisticated analysis of risk & exposure 4. Other Participate in enterprise risk assessment activities, and conduct other audit engagements, including advisory engagements Participate in and support special reviews or investigations at the request of Global Compliance & Ethics personnel, senior management, or the Audit Committee Maintain existing certifications and seek further certification where appropriate Education Bachelor's degree required One of more of Certified Internal Auditor, Certified Public Accountant, or Certified Fraud Examiner designation required Relevant Experience: 3-5 years in public accounting, internal audit, advisory or global corporation, or a combination hereof. Biotech/Pharmaceutical/Life Science experience preferred. A strong candidate will be our “go to person” to solve problems, and get stuff done. Attention to quality and details, data-driven, critical thinking, and good analytical skills are essential to this role. Essential Skills: Ability to work with ambiguity, and respond to a rapidly changing, highly innovative environment Candidate must be skilled and exhibit professional savvy and ability to interact with various levels of management Proactively seeks knowledge, new task, and responsibilities. Highly self-motivated and able to work independently Excellent in developing high quality presentations, Excel formulas and data analytics Knowledgeable in SAP or other ERP systems, and visualization solutions Working knowledge of Data Analytic tools such as Power BI, exposure to AI/ML techniques Ability to organize projects and work responsibilities. Prioritize effectively, and meet deadlines Ability to travel up to 25%; both domestically and internationally Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. DutiesAlternate Sat, Sun-Tues 1800-0700 -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations -Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations -Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) -Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel-Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands. Skills-Prior batch record execution or review experience -Prior experience in investigation, change control, other Quality Management Systems (QMS) -Working knowledge of cGMPs -Excellent written and verbal communication and interpersonal skills -Must display strong analytical and problem-solving skills -Manufacturing and Manufacturing Sciences experience preferred EducationB.S. in scientific discipline or equivalent work experience. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

We are seeking a highly skilled and motivated research intern to join the BRAID team (Biology Research | AI Development) within our Computational Sciences organization. At BRAID, we develop machine-learning methods for different applications in drug development. Within the clinical team in BRAID, we focus on building machine-learning methods to improve the design of early clinical trials. Fundamentally, we collaborate with clinical scientists, biologists, and engineers to design the next-generation clinical trials. The successful candidate for this role should have practical experience working with knowledge graphs, large language models, and state-of-the-art machine-learning libraries. Ideal candidates would have a working knowledge of graph-based transformers and be familiar with clinical data or electronic health records (EHR). This internship position is located in South San Francisco on-site. The opportunity Design and implement novel graph-based methods applied to knowledge graphs and tailored to the complexities of clinical trial data. Train large-scale models using cloud and HPC infrastructure Deliver high-quality code and actively participate in code reviews Keep accurate and timely records of research findings and progress If suitable, submit findings to a relevant conference or journal Program Highlights Intensive 12-week, full-time (40 hours per week) paid internship. Program start dates are in May and June 2024. Ownership of challenging and impactful business-critical projects. A stipend, based on location, will be provided to help alleviate costs associated with the internship. Work with some of the most talented people in the biotechnology industry. Final presentations of project work to senior leaders. Lead or participate in intern committees to design and coordinate program events and initiatives. Professional & personal development curriculum throughout the program, including networking opportunities, workshops, and panel discussions. Participate in volunteer projects, social events, and team-building activities. Who you are (required) Required Education: Must be pursuing a Ph.D. degree Required Majors: Computer Science, Machine Learning, Statistics, Mathematics, Physics, Informatics, Bioinformatics, Health Informatics, or a related field. Required Skills: Experience with LLMs and agent-based workflows Experience with large structured databases such as knowledge graphs Experience with training graph-based machine learning models Strong programming skills with practical experience working with large datasets Proficient in Python and experience with state-of-the-art machine learning libraries (PyTorch, JAX) Familiarity with fundamental ML concepts and modern ML architectures (e.g., transformers) Preferred Knowledge, Skills, and Qualifications: Strong publication record and experience contributing to research projects via publications in conferences such as NeurIPS, ACL, ICML, ICLR Previous experience with large clinical datasets (EHR, RWD) Previous experience with biology concepts Excellent communication, collaboration, and interpersonal skills. Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Relocation Benefits are Not Available for This Job Posting The expected salary for this position based on the primary location of California is $50 hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. #GNE-R&D-Interns-2025 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Role: Associate Director, Global Medical Affairs Learning and DevelopmentSummary Role Description:The Associate Director, Medical Affairs Learning and Development will be responsible for developing and implementing comprehensive training programs for the Medical Affairs team. This role will ensure that all medical team members are equipped with the necessary knowledge and skills to effectively communicate scientific information both internally and externally, engage with healthcare professionals, and support the medical strategies of the organization.Key Responsibilities: Development and execution of learning plans to meet the needs of Global Medical Affairs (GMAF) employees, including needs assessment, design and development, implementation, and evaluation of learning solutions. Performance consult with key stakeholders to proactively identify Medical Unit needs (gaps) and the training strategy (if applicable) that can meet that need. Needs Assessment: Analyze training needs through surveys, interviews, and performance evaluations to identify areas for improvement. Training Program Development: Design and deliver training programs focused on scientific knowledge and skills needed for medical teams to execute on medical plan strategy Content Creation: Collaborate with subject matter experts and/or vendors to create engaging and effective learning materials, including e-learning modules, workshops, and seminars. Including the curation of developed content for streamlined curriculums. Learning Program Pull-through and Evaluation: Ensure learning activities have clear pull-through/reinforcement action plans for pull through within regions/counties. Including plans for monitoring and evaluating the effectiveness of training programs, adjusting as needed to ensure continuous improvement. Industry Trends: Stay current with industry trends, regulatory requirements, and best practices in Medical Affairs and adult education. Cross-Functional Coordination: Coordinate with cross-functional teams, including R&D, Commercial, legal and Compliance, to ensure alignment of training initiatives with organizational goals. Medical Engagement: Ensure external facing GMAF personnel are competent in the areas of product and disease knowledge, compliance, and presentation of external content. Data Dissemination: Coordinate timely training on program data releases (congress activity, manuscripts, press releases etc.) Project management: Develop and maintain project plans, including timelines, milestones, and resource allocation. Presentation Skills: Deliver clear, engaging, and informative presentations to diverse audiences, effectively conveying complex information and facilitating discussions. Qualifications: Advanced degree in a life sciences-related field preferred or comparable experience in life sciences field Minimum of 3 years of experience in Medical Affairs or a related field Minimum of 3 years of experience in Learning and Development function or equivalent Proven experience in designing and delivering training programs, preferably within the pharmaceutical or healthcare industry Strong understanding of adult learning principles and instructional design Excellent communication and presentation skills Ability to work collaboratively with cross-functional teams Strong organizational and project management skills Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

2025 Summer Intern - Early Clinical Development Informatics, Digital Transformation Office Digital health technologies such as wearable or proximal sensors are increasingly being used to enhance the drug development process through the collection of high-fidelity patient data. These innovations may bring increased efficiency to clinical trials, but succeeding in this integration requires careful evaluation, testing, and deployment to best support clinical development. In this role you will join the gRED Digital Transformation Office's digital health group to develop and deploy patient-facing technologies to streamline drug development. You will meet with Clinical Science, Operations, Informatics, and Analytics stakeholders to understand the disease measurement needs to evaluate the efficacy and safety of novel drugs. You will support the development and deployment of these technologies within the clinical trial ecosystem. You will gain hands-on experience in the day-to-day activities within ECD (Early Clinical Development), while also obtaining a high-level understanding of the execution of clinical trials needed to bring drugs to patients. You will also have an opportunity to get exposure to a range of cross-functional disciplines and across multiple therapeutic areas including oncology, immunology, neuroscience, metabolism, infectious disease, and others. Example areas of focus include: technology evaluation and deployment planning, deployment in interventional clinical trials, generating study documents, and study protocol writing. This internship position is located in South San Francisco, CA, on-site The Opportunity * Develop or contribute to the deployment of high impact digital health technologies that support endpoint development in Genentech early clinical development trials. * Work seamlessly with a lean cross-functional team across Early Clinical Development and potentially beyond with other Roche digital health functions. * Interview and interact with internal and external key stakeholders, synthesizing themes, pain points and opportunities * Present your internship project and learnings in one of our internal forums Program Highlights * Intensive 6 months full-time (40 hours per week) paid internship. * Program start dates are in May/June (Summer) * A stipend, based on location, will be provided to help alleviate costs associated with the internship. * Ownership of challenging and impactful business-critical projects. * Work with some of the most talented people in the biotechnology industry. Who You Are Required Education: * Must have attained a Bachelor's Degree Required Majors: Life sciences, clinical research/trials, & hardware product development or engineering, including human factors Required Skills: * Previous experience or familiarity with drug development trials, especially early phase trials * Knowledge of digital health technologies and their underlying hardware and software componentry, especially remote monitoring including vital signs or virtual reality systems * Excellent problem-solving abilities -- able to articulate a problem statement when processes may be complex and/or ambiguous * The ability to work independently and proactively with minimal guidance * Highly skilled in interpersonal communication, writing, and presentation skills; including persuasion and influence Preferred Knowledge, Skills, and Qualifications * Excellent communication, collaboration, and interpersonal skills. * Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. * Experience in the general healthcare sector -- possibly in a hospital, clinic, insurance or health-tech startup * Familiarity with Design Thinking, Agile, or Lean methodologies Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of California is $45/hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. #GNE-R&D-Interns-2025 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Overview: Our full time Research Associate I position will help to develop in vivo methodologies, perform data acquisition and analysis, and disseminate experimental findings to internal scientific teams. Ability to work both somewhat independently and in a collaborative cross functional team setting. Position will report to the team's scientist. Education & Experience: • Bachelor's degree with a minimum of 2 years of requisite experience or Master's degree in Biology or closely related field is preferred. • In vivo and mouse handling skills are essential. • At least 4 years of hands-on experience in rodent models of disease is desired. • Ability to recognize and adhere to IACUC standards of in vivo research is essential. • Candidates with experience in cardiac physiology, mouse ECG or ultrasound, working heart or Langendorff methods and instrumentation will be plus. • Ability to work well with a dynamic team to accomplish shared goals is essential. • Ability to work with Microsoft Excel, Lab Chart software, and statistical software such as Prism or Sigma Stat is desired. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

We are seeking a highly skilled and motivated research intern to join the BRAID team (Biology Research | AI Development) within our Computational Sciences organization. At BRAID, we develop machine-learning methods for different applications in drug development. Within the clinical team in BRAID, we focus on building machine-learning methods to improve the design of early clinical trials. Fundamentally, we collaborate with clinical scientists, biologists, and engineers to design the next-generation clinical trials. The ideal candidate should have hands-on experience in developing generative AI or causal ML methods. Experience with clinical / biological data, multivariate time series, or multimodal data is highly desirable. This internship position is located on-site in South San Francisco. The Opportunity Design and implement novel generative AI / causal ML methods for clinical trials Train large-scale models using cloud and HPC infrastructure Deliver high-quality code and actively participate in code reviews Keep accurate and timely records of research findings and progress If suitable, submit findings to a relevant conference or journal Program Highlights Intensive 12-week, full-time (40 hours per week) paid internship. Program start dates are in September (Fall). A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry. Who You Are Required Education: Must be pursuing a PhD (enrolled student). Required Majors: Computer Science, Machine Learning, Statistics, Mathematics, Physics, Bioengineering, or a related field. Required Skills: Deep understanding of Causality and Causal Reasoning, with active research involvement in Causal ML OR in-depth knowledge of current SoTA in Generative AI, with ongoing research contributions in the field Strong programming skills with practical experience working with large datasets Proficient in Python and experience with state-of-the-art machine learning libraries (PyTorch, JAX) Familiarity with fundamental ML concepts and modern ML architectures (e.g., transformers) Preferred Knowledge, Skills, and Qualifications: Excellent communication, collaboration, and interpersonal skills. Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Strong publication record in conferences such as NeurIPS, ICML, ICLR Previous experience with large clinical or biological datasets Relocation benefits are not available for this job posting. The expected salary for this position based on the primary location of California is $50 hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. #GNE-R&D-Interns-2025 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. SUMMARY: The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects. The Business Operations group within Strategic Research and Development Operations (SRDO), is the center of excellence for providing industry best practice operational support for the conduct of BioMarin's global trials, including vendor and site contract management, strategic vendor oversight, and financial spend analysis and management. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in vendor and trial site spend, by managing the development, negotiation and execution of vendor and site budgets and contracts, and managing the financial and resource projections across projects and trials. JOB DESCRIPTION/PROJECT: The Intern is responsible for assisting with development of vendor/site contracting strategy, analyzing and negotiating budgets and contracting terms, drafting and/or reviewing and managing the execution of the vendor and site budgets, and invoice/purchase order management throughout the contract lifecycle. The intern will also be responsible for developing and implementing functional projects focused on improving effectiveness or efficacy of department systems and processes. Required Skills: * Strong computer skills in database management and document preparation (Word, PowerPoint, Excel); * Excellent organization and time-management skills; must be able to demonstrate agility in prioritizing assigned work * Strong written and verbal communication skills; must be able to communicate effectively with outside parties and serve as a liaison among department personnel and business partners, and proactively communicate relevant issues and deadlines; * Must be detail-oriented, self-motivated, a quick learner, and have a strong work ethic; Desired Skills: * Relevant experience working in the pharmaceutical industry (including CROs) * Relevant technical experience working with contracts and business operations * Experience in the following applications: oMS SharePoint, Teams, Power BI oBOARD (business intelligence software) oDocuSign/DocuSignCLM oCoupa oOracle oAriba oIcertis Qualifications/Eligibility: * BA/BS in finance, accounting, legal, health sciences, or related degree. * Must be available to work full time, 40 hours a week. * Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program. * Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Some positions will be open to remote interns, but employee must be within United States borders. Benefits of a BioMarin Internship: * Paid hourly wage, paid company holidays, and sick time * Apply skills and knowledge learned in the classroom to on-the-job experiences * Comprehensive, value-added project(s) * Develop skills specific to your major. * Opportunities for professional development by building relationships and learning about other parts of the business. * Participate in company all hands meetings, monthly community lunches * Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks * Access to Employee Resource Groups Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $21 to $25 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Our Culture From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Summary The Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program and product development, and other resource or budgetary medical writing requirements for that/those program(s) Responsibilities * Oversight responsibilities for Medical Writing staff * Works with the Head of Medical Writing to ensure appropriate CMW deliverables planning for specified clinical development program(s), including resource forecasting and allocation, timelines, and budget * Works with CMW line management to establish and maintain timelines for program planning. * Acts as management-level author/reviewer for CMW and other Development Sciences deliverables, where such review/authoring is required by SOPs or other controlled process documentation * Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met. * For outsourced projects, performs vendor management tasks (including but not limited to reviewing contract proposals, conducting interviews, preparing and conducting onboarding sessions, and providing oversight for external writers) * Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports * Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (e.g. PSURs, DSURs) * Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries). * Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes * Represents CMW at cross-functional team meetings (eg, study team, development team, other sub-teams). * Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials * Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. * Oversees development and review of standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments * Works effectively with cross-functional groups within BioMarin * Other tasks as assigned. Education & Experience * Masters (MS) or higher degree preferred; scientific focus desirable. * Minimum requirement: At least 10-years of experience as a medical writer in the pharmaceutical industry. * Evidence of medical writing career development desirable, e.g. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. Relevant Experience Fulfills one of the following: At least 10 years of experience as a medical writer in the pharmaceutical industry Management * Minimumof3yearsadministrative and/orfunctional management experience asa managerofamedicalwriterteamordepartmentin aclinical developmentsetting. * Demonstratedleadershipabilities. * Demonstratedabilityto plantimelinesandresourcesformultipledocumentationprojects withshiftingpriorities. * Experiencewithbudgetingdocumentationprojects. * Experienceselectingvendors,establishingworkingrelationshipswithvendors, andoverseeingvendordeliverables. * Experienceestablishingpartnershipswithcross-functionalgroupsin aclinicaldevelopmentsetting. * Experiencewithdelegatingandoverseeingprojectsandtasks. * Experiencewithestablishingdepartmentalandcompany-level processesandprocedures. * Experiencecoachingor mentoringmedical writersbothinbehavioralandtechnical areas. Clinical Studies * Able to mentor or train others in clinical study concepts, design, and documentation * Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets. * Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. * Advanced applied knowledge of: o documentation required for the conduct of clinical studies o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) o study results reporting o integrated results reporting * Direct experience with documentation in all phases of drug development. Medical Writing * Writing high-quality documents that support corporate goals and objectives. * Ability to mentor, train, or manage others in the following: o Routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. o Interpreting data from tables, graphs, and listings o Creating in-text data presentations (including complex tabular and graphical clinical data presentations) o Interpreting basic clinical laboratory tests o Researching literature o Understanding concepts of coding dictionaries (MedDRA, WHO Drug) o Preparing high-quality clinical and regulatory documents (protocols, IBs, clinical study reports, ICFs). Computer/office equipment Skills * Proficiency and ability to train/mentor others in the use of Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, and PowerPoint. * Proficiency with MS Project/Project Server * Experience using document management software (e.g. SharePoint, Veeva) * Experienced with scanners, printers, and copiers. Regulatory * Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs: o 'standalone' regulatory documents (e.g. protocols, investigator brochures, clinical study reports, IND annual reports) o Clinical sections of pre-submission meeting packages (e.g. pre-IND or end-of-Phase 2 meetings), Orphan Drug Applications, CTAs, IMPDs, etc. o Targeted Product Profile, Package Inserts/Product Labels (using structured product labeling guidelines) o Responses to FDA queries and inspection findings * Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US, EU and RoW submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances. * Ability to provide leadership for presentations to regulatory authorities and regulatory inspections. Project Management * Ability to plan, resource, assign, and keep executive management appraised of the status of multiple simultaneous document development projects (stand-alone and complex dossiers) with shifting priorities * Ability to support staff in renegotiating timelines during development as necessary. * Good conflict management skills. Communication * Capable of well organized, concise and clear written and verbal communication. * Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. * Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $ 149,400 to $ 224,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. As a Director in Regulatory Affairs, CMC, you will be responsible/accountable for: Responsibilities related to a Global Regulatory CMC Product Lead in development of global regulatory strategy and preparation of global CMC Regulatory strategy document for assigned commercial and/or clinical product submissions Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of BioMarin's commercial and/or clinical programs; timely preparation and submissions of global regulatory filings including, clinical trial and marketing applications, post-approval variations and license maintenance activities. Conducting a risk-based evaluation of proposed manufacturing changes for regulatory impact to registered information and providing strategic regulatory guidance for optimal implementation of changes. Researching and interpreting global CMC regulations and provide regulatory guidance to Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization. Representing the Regulatory Affairs CMC function on assigned cross-functional project teams within Regulatory, Manufacturing, Sites, Quality. Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. Developing excellent relationships with colleagues and cross-functional stakeholders in WWRD and Technical Operations. Providing advice (strategic and tactical) junior level Reg CMC (if applicable) on key projects Periodic travel to attend meetings and/or conferences EXPERIENCERequired Skills: At least 12-15 years of experience in Regulatory Affairs CMC or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to both development and commercial phases of product lifecycle. Combination products experience desirable. Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the US, EU and Latin America, Eastern European/Middle East, Asia Pacific, Japan markets. Experience in assessing post-marketing changes. Proven ability to lead cross functional CMC teams on projects and sub-teams. Thorough understanding of relevant CMC drug development regulations and guidelines. Outstanding interpersonal and communication (written and verbal) skills is required. Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO's in the international markets. Desired Skills:Essential US, CA, EU Regulatory CMC experience Has lead authoring teams for initial submissions through approvals for MAA and Variations Biologic and Small Molecules experience Experience with coaching, training and mentoring team members. Proven ability to successfully interact with Regulatory Authorities. Strong background in chemistry, molecular biology, or similar is desirable A plus Project management skills are a plus. Device/Combination products experience, a plus Experience with global dossier and document management system EDUCATIONBA/BS degree in life sciences in chemistry, molecular biology, or similar is required. Advanced degree preferred. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of Position The NPD Manager guides the design, development, documentation, and verification of incremental product changes and improvements on complex flexible instruments. You will manage a design team and is responsible for project schedules, product performance against requirements and the management of a multi-disciplinary group of engineers and other technical personnel to ensure efficient product development Essential Job Duties * Provide vision for technical project team and foster environment that encourages creativity, risk taking, and crisp execution * Develop working knowledge of external customer needs/requirements to ensure product designs provide value to patients, physicians and hospitals * Establish group goals and team member work goals consistent with overall product development goals * Assign tasks, set priorities, establish metrics, and track progress * Assess employee performance and provide coaching to improve performance * Manage, coach, and mentor engineers, technicians, and drafters as required. * Ensure design engineers follow appropriate design history file guidelines per FDA requirements and hold design reviews in accordance with product development procedures * Provide engineering resources to support Manufacturing, Supplier Engineering, Test Engineering, and Quality to facilitate transfer of designs * Provide administrative leadership / control for planning, staffing, budgeting, and project/program cost tracking. Qualifications Required Skills and Experience * Minimum 6 years of experience designing, flexible, endoluminal Medical Devices. * Minimum 3 years as a people manager, or equivalent project/team leadership, with proven ability to work well in a team environment * Hands-on engineering manager with the proven ability to work with highly technical teams * Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer * Knowledge of and experience with CAD and other tools that drive design excellence * Experience with root cause analysis and design of experiments * Proven project management, planning, and change management skills * Ability to guide/influence cross functional teams in the design of complex medical systems * Experience designing products in a highly regulated environment * Excellent communication (written, verbal), presentation and documentation skills * Effective people management abilities with capability to ensure team success (staffing, productivity) as well as career development of team members. Required Education and Training * Minimum BS or higher in Mechanical Engineering or equivalent Preferred Skills and Experience * Post-graduate study, MS or PhD in Engineering or equivalent work experience preferred. * Experience in sustaining phase for high volume products * Experience with steerable catheter design and manufacturing * Working knowledge of robotic system design including hardware and algorithms. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed. Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. EEO and AA Policy We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Who We Are From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Duties * Synthesis, optimization, and high-quality delivery of various polymer, protein/peptide, and lipidated bioconjugates in support of discovery and development of novel therapeutics, with an emphasis on oligonucleotides * Development and implementation of new linker chemistries/spacers and bioconjugation methods for targeted drug delivery * Leveraging appropriate purification and analytical characterization approaches for QC and validation * Collaboration with internal and external partners for material transfer to support in vitro and in vivo POC experiments; assemble data packages and maintain quality control documentation through Benchling for final product delivery. * Effectively partner with cross-functional teams, sharing insights, troubleshooting issues, and driving science forward from the bench * Serve independently as bioconjugation technical lead and subject matter expert for internal and external project communications * Perform data analysis, interpret, and present results during internal and external meetings; attend and participate in scientific proceedings. * Prepare and optimize chemistry SOPs * Participate and present data and share responsibility for project milestones Skills * Extensive experience with different bioconjugation strategies and optimizations thereof for polymers, proteins/peptides, lipids, oligonucleotides and other biomolecules * In-depth experience in bioconjugate purification techniques including various liquid chromatography methods (e.g. RP, IEX, SEC, HIC, affinity, FPLC) and membrane filtrations (e.g. TFF) * Prior experience in biochemistry techniques and analytical methods such as SEC-MALs, LCMS, SPR/BLI, ELISA, SDS-PAGE, enzyme activity assays, etc. * Willingness to learn new bioconjugation chemistries or delivery modalities and work across diverse therapeutic areas to develop protein therapeutics. * Strong analytical mindset and chemistry problem-solving with creative thinking * The position requires organization skills, attention to detail, self-motivation, and strong teamwork in a fast-paced setting Education * Ph.D. in Chemical Engineering, Chemical Biology, Chemistry, or related fields is required; Scientist 1 will have 0-2 years of industry/post-doc experience relating to drug development * Strong foundation in macromolecular chemistry, bioconjugation, analytical chemistry and/or chemical biology is strongly desired. * A record of accomplishments/publications in relevant scientific discipline and some hands-on experience in oligonucleotide delivery is preferred but not required. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 51 to $ 75 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. In the U.S., the salary range for this position is $ 51 to $ 75 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Commercial Our Commercial organization leads our global sales and marketing strategies around the world. Our integrated team continues to solidify BioMarin's commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. Reporting to the VP, Business Insights & Commercial Excellence, the Global Head of Digital is a newly created critical senior leadership role responsible for defining and executing BioMarin's global commercial digital and omnichannel strategy. This role will drive digital transformation across the commercial organization (Global, Regional, and Local Markets), establishing the company as a leader in digital engagement and customer experience with providers, patients, and payers. You will be a key driver in advancing BioMarin's ambition to become a leader in omnichannel excellence by leveraging data, digital and analytics to inform customer-centric execution.You will lead a diverse team focused on building a new global commercial capability for BioMarin, partnering closely with Business Units, International Region Leadership, Global Commercial Operations, Information Technology, and other key stakeholders. Responsibilities: Develop and champion the global vision and roadmap for BioMarin's cross-portfolio global commercial digital and omnichannel strategy, including implementation plans and digital capability development across commercial teams. Lead and develop a high-performing global digital team, fostering a culture of innovation and collaboration; position the team as a center of excellence and trusted partners for the enterprise. Oversee the creation, deployment, and optimization of customer journeys that leverage multiple digital and traditional channels. Partner with marketing, sales, and medical teams to align touchpoints with customer needs, therapeutic objectives, and compliance standards. Develop and manage an omnichannel calendar to ensure seamless integration of campaigns, events, and engagement initiatives. Drive strategic initiatives to evolve the operating model, optimizing customer, patient, and portfolio performance; proactively identify and implement scalable solutions. Oversee the execution of digital operations across key areas, including CRM, marketing automation, websites, content management, lead management, sales enablement platforms, paid media, SEO, and other relevant digital channels. Own campaign operations across websites and omnichannel campaigns, ensuring seamless execution and alignment with strategic goals. Establish enhanced customer insight capabilities and drive efficient content sharing globally. Serve as the single point of contact for new digital projects or enhancements, ensuring all digital and omnichannel initiatives have appropriate oversight, engaging the right internal and external stakeholders. Partner closely with colleagues from Business Insights & Analytics (BI&A) and Performance Excellence (PE) to build the necessary decision support infrastructure, combining and mining data sets to support core brands across regions and markets, and define key performance indicators (KPIs) to measure the success of digital strategies and initiatives across all channels. Coordinate program updates and progress reports for leadership, highlighting key milestones, risks, and outcomes. Manage relationships with agencies-of-record (AORs) and partners, collaborating with procurement on contracts, financials, and performance management; establish and enforce standards and best practices for collaboration with 3rd-party agencies, ensuring global consistency, quality, and compliance. Maintain deep expertise in healthcare delivery and digital customer engagement trends, partnering with brand teams to leverage current capabilities and shape the future roadmap. Champion a culture of data-driven decision-making and digital innovation across the commercial organization. Lead change management efforts to ensure teams are equipped to execute within an omnichannel framework. Serve as a trusted advisor to cross-functional teams, bridging gaps between strategy, data, and execution. Candidate Profile:We are seeking a highly data, digitally driven, passionate, self-motivated, strategic and innovative senior leader with a proven track record of driving digital transformation, delivering measurable business results in the pharmaceutical industry, with a healthy ambition & hunger to make an impact for patients and BioMarin overall. Knowledge, Abilities & Experiences: 10+ years of experience in digital marketing, omnichannel strategy, and digital transformation within the pharmaceutical industry. 5+ years of experience leading and developing high-performing digital teams. Deep understanding of the pharmaceutical industry landscape, including regulatory considerations, compliance requirements, and ethical guidelines for digital engagement. Proven experience developing and executing global omnichannel strategies that have resulted in measurable business impact. Expertise in integrating data-driven insights to inform decision-making and execution. Strong analytical and data interpretation skills, with the ability to translate data into actionable insights and recommendations. Strong leadership and influencing skills to drive alignment across diverse teams and stakeholders. Ability to think strategically and act tactically, balancing long-term vision with immediate execution needs. Proficiency in navigating complex organizational structures and ensuring stakeholder buy-in. Key Technical Competencies Required: Strong understanding of digital marketing technologies and platforms, including: CRM (e.g., Salesforce.com) Marketing Automation (e.g., Marketo, Salesforce Marketing Cloud) Customer 360 platforms (e.g., Zaidyn) Next Best Action tools (e.g., Zaidyn, Salesforce Einstein) Web Content Management Systems (e.g., Adobe Experience Manager, Sitecore, Wordpress) Sales Enablement platforms (e.g., Veeva Engage, Seismic) Analytics and data visualization tools (e.g., Google Analytics, Tableau) Consent Management Platforms (OneTrust) Customer Data Platforms (e.g., Salesforce CDP, Twilio, Tealium) Personalization Engines (e.g., Salesforce Marketing Cloud, Adobe Target) Strong ability to leverage analytics tools (e.g., Tableau, Power BI) to guide omnichannel planning and optimization. Proficiency in designing and implementing multichannel customer experiences. Knowledge of industry regulations (e.g., FDA, GDPR, HIPAA) related to digital engagement. Strong project management experience, agile methodologies, demand management and prioritization. Expertise in managing complex projects, timelines, and cross-functional teams to deliver results. Ability to manage vendors, contracts and budget activities required Excellent influencing skills, with demonstrated ability to work collaboratively and effectively with key business partners, IT leadership teams, and external service providers. Experience with digital channels and tactics, including website development, content marketing, social media, search engine optimization (SEO), paid media, email marketing, personalization and mobile marketing. Excellent communication, interpersonal, and presentation skills, with the ability to influence and collaborate with stakeholders at all levels. Bachelor's degree in marketing, business, or a related field; MBA or master's degree preferred. Competencies: Strategic Thinking: Ability to develop and articulate a clear vision and strategy for digital transformation. Execution Excellence: Proven ability to drive results and deliver on commitments. Collaboration and Influence: Ability to build strong relationships and influence stakeholders across functions and levels. Innovation and Agility: Embraces new ideas and adapts quickly to changing environments. Communication and Presentation: Excellent communication and presentation skills, with the ability to articulate complex concepts clearly and concisely. Leadership and Team Development: Ability to inspire, motivate, and develop high-performing teams. Location:San Rafael, CA Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Corporate Groups It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin. Global Sourcing and Procurement The Global Sourcing and Procurement (GSP) organization is accountable for driving and delivering Procurement value to support stakeholders' and organizational strategic objectives. The GSP function delivers value to BioMarin by leading transformational change and implementing industry-leading category strategies that directly support the corporate strategy. The GSP organization leverages market intelligence, subject matter expertise, and business insights in the procurement of goods and services and management of BioMarin's growing third-party spend of $1B+. Through collaboration with our external suppliers and internal business partners, GSP helps bring innovative new medicines to patients. Role Scope: This Senior Manager must implement industry-leading procurement practices, develop deep and wide relationships with stakeholders, drive innovation and continuous improvement in the ways of working. The successful candidate must be results oriented and drive to measurable outcomes by delivering hard and soft savings, develop appropriate SLA's/ KPI's to track performance, and create a multi-year road map of opportunities. Responsibilities: The role is responsible for supporting BioMarin's supply chain operations across the full value chain, including - and not limited to - commercial distributors, comprehensive category management, sourcing and procurement of goods and services, supplier relationship management (SRM), and risk mitigation. This includes developing category strategies by engaging stakeholders, understanding their needs, and developing strategies that align with those needs in an industry-standard manner. Category Management: Develop comprehensive category strategies for warehousing/storage, distribution, transportation, global trade category strategies, and commercial distributors. Drive execution of associated projects and programs to deliver optimized Total Cost of Ownership (TCO) with risk mitigation considerations that provide assurance of supply. Includes stewardship of data integrity in systems including GEP Smart, Coupa, and SAP Ariba (pricing, vendor master, category taxonomy). Sourcing and Contracting: Effectively execute end-to-end sourcing process for services, including supplier evaluation, selection, and end-to-end contract management in line with business needs. Lead complex contract negotiations to achieve BioMarin's operational and business goals. Complex engagements may require a detailed strategic plan in partnership with the Legal department and functional stakeholders. Supplier Relationship Management: Implement and lead the SRM process, in partnership with key stakeholders, to optimize supplier engagement and attainment of company / functional goals. Maintain an in-depth understanding of supplier capabilities, capacity, and overall financial stability to mitigate risk of business disruption. Skills Required:Demonstrated experience with sourcing and procurement in the supply chain industry, including the regulations associated with supply chain management. Specific knowledge and expertise in sourcing supply chain services, logistics, transportation, and warehousing. Strong skills in category strategy development, negotiation, stakeholder management, and supplier management. Proficient project management skills are required to develop, implement, and maintain category / sourcing plans Qualifications: Bachelor's degree in engineering, supply chain, or life sciences; MBA/MS desirable, C.P.M. desirable. 7+ years of strategic procurement experience with extensive knowledge and experience in category management, sourcing, contract negotiations, and supplier management, preferably within logistics and with commercial distributors in the biotech industry Knowledge of global trade compliance policies and procedures and evolving/existing cross-border trade regulations: This includes demonstrated expertise in managing relationships with commercial distributors to ensure compliance with international trade requirements, as well as optimizing processes for cost efficiency and timely delivery of BioMarin treatments. Familiarity with distributor selection, evaluation, contract negotiations, and performance management is critical to ensuring adherence to regulatory standards and quality expectations while maintaining robust supply chain operations. Familiarity with complex cross-border logistics, customs clearance, and local market regulations in partnership with distributors is essential to achieving seamless product delivery to the patient and/or treatment provider. Experience in biotech / life sciences industry. 3+ years of supply chain logistics experience Strong leadership and communication skills, including solid interpersonal, analytical and presentation skills. Travel Requirements: Periodic travel will be required to various BioMarin sites and supplier locations. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Manufacturing Shift Lead Backhalf Graves SUMMARY BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. RESPONSIBILITIES * Leadership * Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight * Accomplishes tasks through direct and effective coordination * Provides direction and hands-on training for staff * Supports the management of staff with supervisor * Lives department values and sets the standards for others to operate * Fosters an environment of compliance, strong work ethic and ongoing learning * Contribution * Ability to take responsibility for moderate level projects * Effective interaction with peer Leads across manufacturing to create alignment and improvement * Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities * Process Knowledge * Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance * Ability to troubleshoot, identify issues and support resolutions with technical groups * Required to perform ongoing operational tasks in respective work area * Uses scientific thinking and decision making in daily work * Technical Competency * Proven experience with relevant process, theory and equipment * Experience with process automation and functionality * Assist with review and approval of documentation including Batch Records and logbooks * Support the closure of Manufacturing owned Quality Records (deviations, change requests) * Other duties as assigned EXPERIENCE Required Skills: 2-4 years Manufacturing Experience 0-2 years Leading a team Familiarity with manufacturing softwares, Chrome skids, TFF skids Delegating work, leading a team, following production schedule Desired Skills: 2-4 years Manufacturing Experience 0-2 years Leading a team Desired skills is experience with Oracle, MES, Microsoft Teams, communication with groups EDUCATION BA/BS desired not required, 1-2 years leading Manufacturing experience EQUIPMENT Chrome Skids, TFF skids, buffer tanks, labwashers, autoclaves CONTACTS Will interact with manufacturing, automation, facilities, instrumentation, QA, QC SHIFT DETAILS This position is for the Backhalf Graves shift Wed/Thurs-Sat 6pm-7am ONSITE, REMOTE, OR FLEXIBLE Onsite only TRAVEL REQUIRED None Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $ 68,300 to $ 102,500 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.