IBA Molecular Jobs

- 8,337 Jobs
  • Quality Assurance Engineer

    Onkos Surgical 3.9company rating

    Parsippany-Troy Hills, NJ Job

    The Quality Assurance (QA) Engineer II will play a key role in the implementation of Onkos Surgical's Quality Management System and have the opportunity to gain experience across a broad range of quality functions related ISO 13485 and 21 CFR Part 820 compliance. Specifically, the QA Engineer will champion complaint handling, product release procedures and approval, and support to both NCR and CAPA processes. This will require developing relationships and working closely with suppliers. This position will also work with cross-functional teams to provide quality engineering support in the development of technical files to ensure regulatory compliance during product development. Responsibilities Receive, document and process complaints related to product quality and patient safety. Conduct, coordinate and document complaint investigations. Review complaints for possible Adverse Events/MDRs and recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner to meet regulatory deadlines. Review and approve Device History Records (DHRs) and communicate closely with contract suppliers to ensure compliance with Quality Agreements and QMS procedures. Participate in and support NCR and CAPA investigations. Participate in the application of statistical methods to trend NCRs, CAPAs, Complaints, and DHR approval acceptance. Support in Supplier vetting process and maintaining Approved Supplier List. Provide support to Product Development and Operations on design transfer and process validations. Participate in product risk assessment efforts, including failure mode effect analysis (FMEA's). Monitor quality metrics and key process indicators to identify opportunities. Lead and/or participate in multi-departmental initiatives to implement quality improvements. Drive compliance to the QMS and provide QMS training to appropriate team members. Author changes to existing procedures, work instructions, and forms as necessary. Comply with U.S. FDA and ISO requirements, other regulatory requirements, Company policies, operating procedures and processes. Perform other QA and quality control functions as necessary, with appropriate training. Assist in the review of Technical Files. Requirements Minimum of 5 years quality assurance experience in medical device industry. Manufacturing or supplier quality engineering experiences a plus. Working knowledge of CFR Part 820 and 13485 for medical device products. Complaint investigation experience. BS in an engineering discipline. Certified Quality Engineer certification a plus. Experience in root cause failure analysis and change control. Detail oriented and experience in a manufacturing environment a plus. Good verbal (including presentation) and written communication skills. About Onkos Surgical At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will: Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.
    $75k-106k yearly est. 29d ago
  • Vice President of Business Development, Key Accounts - Contract Manufacturing (Personal Care/Skincare)

    Topix Pharmaceuticals, Inc. 3.5company rating

    Amityville, NY Job

    Title: Vice President of Business Development, Key Accounts - Contract Manufacturing (Personal Care/Skincare) Location: Must reside in the New York Metro area and be able to travel as needed (including overnight travel) Industry: Personal Care/Skincare, Contract Manufacturing Job Overview: We are adding to the team and seeking a dynamic, experienced, and hands-on Vice President (VP) of Business Development, Key Accounts, with a proven track record in contract manufacturing for personal care and skincare products. This strategic leadership role is designed for an individual with extensive experience (12+ years) in business development and client diversification. As a key member of our leadership team, you will drive the growth of key accounts, build strong relationships with new and existing clients, and support the expansion of our business across multiple markets. The ideal candidate will possess a combination of strategic vision, deep industry knowledge, and a hands-on approach to execution. You should be comfortable "rolling up your sleeves" and managing day-to-day business development efforts, while also developing long-term strategies for growth. Key Responsibilities: Business Development & Growth Strategy: Develop and execute the overall business development strategy for key accounts within the personal care and skincare contract manufacturing sector. Focus on building a robust pipeline of new business opportunities, expanding existing client relationships, and diversifying the client portfolio. Client Acquisition & Relationship Management: Identify, nurture, and close new business opportunities with high-value accounts. Build and maintain strong relationships with key stakeholders in client organizations, including senior executives, purchasing, R&D, and marketing teams. Revenue Growth & Diversification: Lead efforts to diversify the company's client portfolio across a variety of product categories and markets within the personal care and skincare industry. Focus on both organic growth within existing clients and expansion into new sectors or geographies. Contract Negotiation & Deal Structuring: Oversee the negotiation of contracts, pricing, and terms with key clients, ensuring favorable outcomes that align with the company's strategic objectives and profitability goals. Team Leadership & Collaboration: Lead and mentor the key accounts team. Collaborate closely with other departments (operations, R&D, marketing, finance) to ensure seamless delivery of solutions and services to clients. Market Intelligence & Industry Trends: Monitor industry trends, competitor activity, and market conditions to identify new business opportunities. Keep leadership informed on market dynamics and evolving customer needs. Hands-On Execution: Actively participate in sales and business development efforts, including client presentations, trade shows, and industry events. Be a visible leader who leads by example and isn't afraid to roll up their sleeves to get the job done. Qualifications: Experience: 12+ years of business development experience, specifically within contract manufacturing for personal care or skincare products. A proven track record of securing and growing key accounts, expanding client portfolios, and delivering consistent revenue growth. Industry Knowledge: In-depth knowledge of the personal care, skincare, and/or cosmetics industry, with a strong understanding of manufacturing processes, regulatory standards, and market dynamics. Proven Success: Demonstrated success in identifying, negotiating, and securing large-scale contracts with both new and existing clients. Experience in developing strategies to diversify a client base across various product categories or markets. Leadership Skills: Strong leadership abilities with experience leading and mentoring teams. A collaborative and team-oriented approach to work, with the ability to drive performance and results. Communication & Negotiation: Excellent interpersonal, communication, and negotiation skills. Ability to build relationships with senior stakeholders and decision-makers across a range of client organizations. Strategic & Hands-On: A balance of strategic vision with the ability to execute on the ground. Comfortable with both high-level strategy development and detailed, day-to-day business development tasks. Education: Bachelor's degree in Business Administration, Marketing, or a related field. An MBA or equivalent advanced degree is preferred. Key Attributes: Results-driven with a strong focus on achieving business objectives. Proactive, self-motivated, and able to work in a fast-paced environment. Creative problem solver with a solutions-oriented mindset.
    $137k-203k yearly est. 5d ago
  • Senior Auditor, Quality Assurance IN OFFICE- AUSTIN

    Worldwide Clinical Trials 4.4company rating

    Austin, TX Job

    What the Senior Auditor, Quality Assurance does To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials (WCT) Worldwide Clinical Trials (WCT) processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Mentors other QA auditors. The Senior (Sr.) Quality Assurance Auditor works under the general supervision and guidance of the Manager, QA, Sr. Manager, QA, Director, QA or Sr. Director, QA. What you will do Works with the QA Management to plan, conduct and complete written reports for each audit assigned. Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request. Assists with the management of the Vendor Audit program. Facilitates sponsor audits/regulatory inspections, as assigned. Assists QA Management with review of audit reports to identify improvements that enhance the quality and clarity of the reports. Fosters a good working relationship with internal clients and QA team. Identifies areas for process improvement and provides this information to management. Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits. Provides advice and guidance on regulatory requirements and SOPs. Assists with training and mentoring of less experienced auditors. Assists with creating and presenting GCP/GLP and other related training sessions. Assists QA Management with review of WCT policies and procedures. Oversees the maintenance of records for each audit. What you will bring to the role Sound knowledge of applicable GxP regulations and requirements as well as WCT policies and procedures. Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events. Ability to use logical inferences to understand the “big picture” and long term implications of these issues. Ability to interact professionally and to work independently or in teams. Excellent oral and written skills. Ability to prioritize work and define steps needed to achieve assigned project goals. Ability so speak, read and write English fluently. Experience with Microsoft Word applications and to learn internal computer systems as necessary Your experience Bachelor's Degree preferably in life science and a minimum five (5) years' experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, three (3) of those years must be in quality assurance auditing. Additional experience in a relevant area (clinical setting, laboratory) that is deemed equivalent to education may be applied in lieu of the education requirement.
    $62k-76k yearly est. 16d ago
  • Graphic Designer

    Neilmed Pharmaceuticals 4.0company rating

    Santa Rosa, CA Job

    SUMMARY OF RESPONSIBILITIES: The Graphic Designer will be responsible for developing high-quality visual materials for our medical device products, including packaging, marketing collateral, and digital content. This role requires a strong understanding of design principles, attention to detail, and the ability to collaborate with cross-functional teams to deliver effective and compliant design solutions. KEY RESPONSIBILITIES: Design and produce a variety of visual materials, including product packaging, labels, brochures, presentations, and digital assets for marketing campaigns. Collaborate with product managers, marketing teams, and regulatory affairs to ensure that all designs meet brand guidelines, regulatory requirements, and industry standards. Develop creative concepts and visual storytelling strategies that effectively communicate product benefits and features to target audiences. Conduct market research and competitor analysis to inform design decisions and stay updated on industry trends. Prepare files for print production and work with external vendors to ensure the quality and accuracy of printed materials. Manage multiple projects simultaneously, meeting deadlines while maintaining a high standard of quality. Participate in brainstorming sessions and contribute to team discussions on design strategies and marketing initiatives. Update and create (3D Boxshot) materials for marketing and advertising 3D Models - In 3D graphics, 3D modeling is the process of developing a mathematical representation of any surface of an object in three dimensions via specialized Strata software. Web & social media content NeilMed Piercing Aftercare KNOWLEDGE: Bachelor's degree in Graphic Design, Visual Communications, or a related field. A minimum of 4 years of professional graphic design experience, preferably in the medical device or healthcare industry. Strong portfolio showcasing a range of design projects, with a focus on packaging, marketing materials, and digital content. Knowledge of design principles, typography, color theory, and layout techniques. SKILLS/COMPETENCIES: Proficiency in Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other relevant design software. Familiarity with regulatory requirements for medical device labeling and advertising is a strong plus. Excellent communication and collaboration skills, with the ability to work effectively in a team-oriented environment. Strong attention to detail and the ability to manage multiple projects and deadlines effectively. Benefits Medical. Dental, and Vision Plans 401(k) with 4% employer contribution 50,000 company paid Life Insurance policy Two weeks paid vacation Six paid holidays Sick days per California Employment Law
    $50k-78k yearly est. 29d ago
  • Process Engineer

    Icon Consultants, LP 4.1company rating

    Framingham, MA Job

    MSAT Process Data Science & Digital Transformation - Process Engineer III (Mechanistic Modeling & Process Control) About the Role: Join our Global MSAT organization as a Process Engineer III within the MSAT Data Science & Digital Transformation (DSD) team. You'll be a key driver of data and digital innovation, contributing to best-in-class manufacturing and analytical processes. Specifically, you will be part of the Mechanistic Modeling & Process Control group, responsible for developing and implementing advanced process modeling and technologies, such as digital twins and Process Analytical Technology (PAT), to enhance our understanding, monitoring, and control of manufacturing operations. This role is highly collaborative, bridging R&D and manufacturing to deliver innovative, robust, and cost-effective processes. Key Responsibilities: Process Modeling & Development: Develop mechanistic and hybrid models to predict and understand Drug Substance (DS) and Drug Product (DP) process behavior. Implement advanced process modeling and technologies (digital twins, PAT Raman) to optimize process tech transfer, scale-up, and enable real-time monitoring and control. Process Optimization & Support: Provide modeling expertise and process knowledge to support process investigations and improvement initiatives. Ensure Right-First-Time (RFT) process tech transfer and scale-up. Collaboration & Communication: Collaborate cross-functionally with R&D, Manufacturing, Quality, and Digital teams, as well as external partners. Key Qualifications: Technical Expertise: Proven experience in biopharmaceutical process modeling (mechanistic, hybrid, chemometric e.g. PAT Raman) and process control. Strong understanding of cell culture and bioreactor operations (a plus). Proficiency in advanced data analysis and programming (e.g., Python). Education & Experience: Master's or PhD in Chemical/Biochemical Engineering or a related engineering/science discipline. Minimum 3+ years of relevant industry experience. Why Join Us: Be at the forefront of digital transformation in biopharmaceutical manufacturing. Contribute to the development of next-generation processes that enhance efficiency, robustness, and sustainability.
    $77k-105k yearly est. 22d ago
  • Executive Director, Global Market Access

    EPM Scientific 3.9company rating

    Conshohocken, PA Job

    Job Responsibilities: Develop and execute global market access strategies, addressing payer objections and aligning with lifecycle management for optimal pricing and funding. Collaborate with HEOR to design evidence generation plans, conduct value assessments, and leverage advanced methodologies like AI for data-driven decisions. Advise on pricing, tenders, and market access perspectives, while identifying and mitigating risks related to market access trends. Drive early market access by providing insights on portfolio prioritization, product profiles, and payer recommendations in key markets. Foster cross-functional collaboration with teams like Marketing, Medical Affairs, and Regional Leads to ensure effective strategy rollouts and training. Requirements: 15+ years of Market Access experience within the pharmaceutical industry 5+ years of Global experience required Skilled in identifying business trends and developing strategies for long-term success. Experienced in creating strategies for timely, quality, and affordable patient access. Strong in business acumen, negotiation, strategy, analysis, decision-making, and communication. Capable of influencing and collaborating with senior internal and external stakeholders. Experienced in navigating internal processes, mobilizing stakeholders, and leading teams to exceed performance targets.
    $77k-133k yearly est. 12d ago
  • Formulation Chemist - OTC/ Cosmetics

    Tri Pac, Inc. CDMO 4.0company rating

    South Bend, IN Job

    Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Formulation Chemist (Personal Care - Hair Care/ Skin Care) for immediate addition to our fast growing team. This position is in South Bend, Indiana. Primary Functions Develop and prepare personal care and/or skin care products. Development of aerosol and liquid formulations Understand the needs and restrictions of the customer and develop formulas accordingly. Prepare Specifications for all products developed. Maintain laboratory notebook, including critical processing details and observations. Multi-task to handle 10-15 projects a week. Monitor batch shelf-life stability Calibrate and validate all lab equipment. Conducts and tracks all required performance and stability tests, interprets, records and reports results. Up to date with industry and consumer trends A working knowledge of the global regulatory requirements Perform other duties as needed or assigned. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility Requirements 2-5 years lab/formulation experience Aerosol and working knowledge of propellants required. Knowledge of Access, Excel, Word, Projects Attention to detail, organization and multi-tasking skills. Technical knowledge of chemicals and their functionality to develop and prepare personal care and color products. Knowledge and use of Brookfield viscometers, pH meter, pychnometers, mixers, hotplates Ability to understand processing procedures, fill weights, formula cost implications, ingredient lists, and OTC products in order to be well rounded in the capacity of formulation skills. Knowledge of OTC guidelines/monographs Global formulation skills Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required. Ability to utilize Brookfield viscometers, pH meters, pycnometers, mixers and hotplates. The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position. Must be capable of using a keyboard for computer purposes. Self-motivated Customer focused and Quality Driven Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. *************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.
    $51k-75k yearly est. 8d ago
  • Associate Director/Director, Market Research and Analytics

    EPM Scientific 3.9company rating

    Philadelphia, PA Job

    Key Responsibilities: Primary Market Research: Design, execute, and analyze qualitative and quantitative research studies to inform strategic decision-making. Secondary Analytics: Leverage existing data sources (claims data, prescription trends, competitive intelligence, etc.) to generate insights that drive business growth. Managed Markets or Consumer Insights: Develop insights into payer strategies, formulary access, and reimbursement trends. Analyze consumer behavior and non-personal promotion effectiveness. Cross-Functional Collaboration: Work closely with commercial, brand, and market access teams to translate insights into actionable recommendations. Vendor & Budget Management: Select and manage external research partners while ensuring cost-effective execution of research projects. Reporting & Communication: Synthesize and present findings to leadership and key stakeholders to inform strategic planning. Qualifications: 8+ years in market research, analytics, or a related field within the pharmaceutical industry Bachelor's degree required; advanced degree welcomed Expertise: Strong background in managed markets or consumer insights with non-personal promotion is required. Proven experience with both primary and secondary research methodologies. Understanding of US healthcare dynamics, including payer, provider, and patient perspectives. Technical Skills: Proficiency in data analytics tools, survey platforms, and market research methodologies. Your resume will not be considered if you don't have the qualifications above.
    $95k-178k yearly est. 29d ago
  • Strategic Portfolio Planning Lead

    UCB 4.3company rating

    Atlanta, GA Job

    We are seeking a Strategic Portfolio Planning Lead to join our Immunology Patient Value Unit (IPVU) in Atlanta, GA. Note: This is a hybrid role and will not be remote. About the role As the Strategic Portfolio Planning Lead in the US Immunology Patient Value Unit (iPVU), you will: Lead in strategic planning, including bringing the business view in long-range forecasts, financial planning, brand planning, strategy integration. Drive some key enterprise initiatives. Serve as the primary point of contact with all internal stakeholders at local, regional, and global levels, and act as a champion for the US Immunology team. Contribute to strengthening the ONE Immunology team from design to execution. Who you'll work with This critical position within UCB IPVU involves collaboration with various stakeholders, including senior leadership teams. You will represent and champion US Immunology. Your key partners will include (list is non-exhaustive): Medical, Marketing, Sales, Patient services, and Ecosystem teams. Insight-to-Impact teams Compliance teams Global teams Major Accountabilities/Responsibilities Develop and implement business planning processes, including long-range forecasting, patient value brand planning, and tactical planning, informing the yearly budgeting process. Serve as an expert on business planning processes and recommend continuous improvements to connect strategic choices to tactical implementation. Act as the primary contact for US iPVU with global colleagues on business planning processes and key strategic enterprise initiatives. Manage and execute internal communication development, including monthly Executive Committee reporting and global newsletters. Develop impactful strategic presentations and documents for executive leadership, influencing strategic vision and performance. Lead key enterprise projects with strong recommendations for action and implementation in the US as well as leverage your deep understanding of business priorities and stakeholders to assess the competitive environment and its strategic implications on the US market, affecting both short- and long-term planning and forecasting. Utilize your commercialization focus and business acumen to champion metrics and impact analyses, supporting continual investment decision-making. Collaborate across the Stakeholder Experience & Value to integrate and connect the entire US team, ensuring consistency and developing portfolio strategy. Interested? For this position you'll need the following education, experience and skills: Bachelor's or Master's Degree 5 to 7 years of experience in the pharmaceutical or healthcare industry or consulting with at least 3 years in marketing or strategic commercial roles Strong understanding of data and US business operations Proven experience in writing and presenting strategic business plans, with the ability to synthesize multiple elements into concise documents Ability to inspire and lead cross-functional teams, coordinating with internal partners in marketing, sales, market research, analytics, forecasting, data governance, MAP, medical, etc. Demonstrated ability to “connect the dots” in a complex and matrix environment, understanding decision-making processes and coordinating with decision-makers and indirect influencers Proven success in executing intra-organizational and interdependent initiatives across executive-level leadership teams.
    $112k-172k yearly est. 30d ago
  • Associate Attorney

    Maya Murphy, P.C 4.1company rating

    Westport, CT Job

    Role Description This is a full-time on-site role for an Associate Attorney at Maya Murphy, P.C. located in Westport, CT. The Associate Attorney will be responsible for providing legal advice, conducting research, negotiating on behalf of clients, and handling files independently and collaboratively with colleagues within the firm. Associate Attorneys join our firm on a partnership track from the first day. Qualifications Legal Advice and Negotiation skills Experience in conducting research Strong analytical and problem-solving skills Excellent written and verbal communication skills Detail-oriented and able to multitask effectively Juris Doctor (J.D.) degree from an accredited law school Admission to the Connecticut bar is required
    $75k-127k yearly est. 22d ago
  • Application Technician - Innovation

    Kerry 4.7company rating

    Clark, NJ Job

    Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role Working with the Innovation Flavourists and Flavour Technologists, you will be responsible for conducting validation and optimization of Taste Technologies that are focused but not limited to Savoury categories via testing in various model and finished applications. You will also work closely with the various application teams understanding their application recipes and ingredients for the assessment of Taste technologies. All development work will deliver in terms of Taste and performance in alignment with the Global Taste Innovation Platform priorities and expectations. Key responsibilities • Assist Innovation Flavourists and Flavour Technologist creating value added Taste products with a point of difference by utilizing innovative technologies and differentiating Taste raw materials. • Assist Flavour Technologist creating model system applications by simplifying commercial finished application recipes whilst keeping the functionality and performance of the recipes. • Based on the technology assessments in model system applications, further assess new flavour ingredients and technologies in finished applications. • Ensures that ingredient and technology functionalities and their unique ratios in the finished applications meet market technology needs and business goals. • Be able to communicate and explain experiment results to technical audience via application demo presentations. • Collaborate with cross functional teams including Global Taste Innovation, Regional Flavourist and EUMs, and Sensory. • Organize and prepare application samples for the tasting sessions for both lab evaluations and sensory panels. • Organize and maintain ingredients and raw materials used in application recipes. • Maintain lab consumables and equipment in safe and hygienic storage. • Preparation and shipment of R&D sample requests keeping internal/external customer informed of delivery times and updates. . Qualifications and skills • Food Science, Chemistry, or Culinary Degree / Bachelor or Masters • 1-3 years work experience in a New Product Development environment • Demonstrates creativity, practical skills & enjoyment of cooking foods • Excellent oral, written communication and ICT skills, with ability to present technical findings • Ability to manage and develop projects • Time keeping and workload management • Self-Starter and ability to work on own initiative. The typical hiring range for this role is $41,446 to $60,768 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements. Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).
    $41.4k-60.8k yearly 16d ago
  • Manufacturing Engineer

    Onkos Surgical 3.9company rating

    Parsippany-Troy Hills, NJ Job

    The Manufacturing Engineer is responsible for leading advanced manufacturing processes, driving process improvements, and ensuring the highest quality standards in the production of orthopedic implants and instruments. This role provides technical expertise, strategic leadership, and hands-on support for process development, automation, and validation while collaborating with cross-functional teams to optimize manufacturing operations. Responsibilities Manufacturing Process Development & Optimization: Design, develop, and implement cutting-edge manufacturing processes for orthopedic implants and surgical instruments. Lead process validation (IQ, OQ, PQ), ensuring compliance with FDA, ISO 13485, and GMP regulations. Identify and implement automation, robotics, and advanced machining solutions to enhance efficiency. Optimize CNC machining, and additive manufacturing processes for cost-effective and high-quality manufacturing/production. Develop work instructions, standard operating procedures (SOPs), and process flow documentation to support manufacturing/production. Continuous Improvement & Lean Manufacturing: Drive Lean Six Sigma, Kaizen, and 5S initiatives to enhance productivity, reduce waste, and improve process reliability. Lead root cause analysis and Corrective/Preventive Action (CAPA) implementation to resolve manufacturing issues. Develop and execute strategies to reduce cycle times, scrap rates, and production costs while maintaining quality standards. Equipment, Tooling, & Technology Advancement: Oversee selection, installation, and validation of state-of-the-art manufacturing equipment and tooling. Work closely with R&D and product development teams to ensure design for manufacturability (DFM) and design for assembly (DFA). Collaborate with suppliers and vendors to identify new materials, coatings, and machining technologies for orthopedic applications. Regulatory Compliance & Quality Assurance: Ensure all manufacturing processes comply with FDA, ISO 13485, and GMP standards. Partner with Quality and Regulatory teams to support audits, inspections, and process documentation. Utilize statistical process control (SPC) and data-driven decision-making to maintain product integrity. Leadership & Mentorship: Provide technical leadership and mentorship to junior engineers and manufacturing teams. Serve as a subject matter expert (SME) in manufacturing engineering, troubleshooting complex production challenges. Collaborate with cross-functional teams, including R&D, Quality, and Supply Chain, to drive innovation and efficiency. Requirements Education: Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field Experience: Minimum of 3 (??) years in manufacturing engineering, preferably in the orthopedic or medical device industry. Technical Skills: Expertise in CNC machining, additive manufacturing (3D printing), and precision assembly. Proficiency in CAD/CAM software (SolidWorks, Mastercam, SmartCam, or similar). Strong background in process validation, statistical analysis, and DOE (Design of Experiments). Experience with automation, and robotics Certifications (Preferred): Lean Six Sigma Black Belt, PMP, or equivalent industry certifications. Soft Skills: Strong analytical skills, leadership, problem-solving, and effective communication abilities. About Onkos At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will: Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.
    $72k-94k yearly est. 11d ago
  • Area Service Manager

    Employment Solutions of New York, Inc. 3.9company rating

    Miami, FL Job

    We are partnering with a client company to hire an Area Operations Manager for 2nd shift to lead a team of Janitorial Supervisors and Cleaning Specialists in Miami Dade County. This is a full time, direct hire position with great benefits and wonderful company culture! If hired, you will plan, direct and monitor your operational area and manage your team to guarantee that work is performed according to contract specifications. Salary range: $45K -$55K +10K variable bonus Requirements: High school diploma or equivalent 3-5 years experience in janitorial management 2+ years of supervisory experience Bilingual (English/Spanish) required Valid driver's license is required Knowledge of modern cleaning techniques and floor care Demonstrated ability to coach, train, motivate, develop, and lead a team Strong customer service skills, work with different levels of internal and external customers. Experience understanding budgets, P/L, and forecasting Skilled at problem-solving, follow-up, and negotiation skills Proficiency with technology; MS Word/ Excel/Outlook; Time clock systems; laptop and cell phone usage. Benefits: Medical Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays Interested? Please send your resume to: ************************
    $45k-55k yearly 11d ago
  • Contract Analyst

    Red Oak Sourcing 3.9company rating

    Foxborough, MA Job

    The entry level Contract Analyst supports Red Oak Sourcing's contract related and data validation activities, primarily focused on contract maintenance and validation, in addition to data entry, auditing and data reconciliations. This position is within a fast-paced, collegial environment, providing the right individual with an opportunity for career advancement and the ability to directly interact with both parent organizations, Cardinal Health and CVS Health. **This is a hybrid role with a required schedule: onsite in our Foxboro, MA location on Tuesday, Wednesday, and Thursday, and remote on Monday and Friday. Relocation is not available for this position.** Responsibilities Timely and accurate execution of contractual activities including contract preparation, validation, contract execution, audits, document retention and related reporting Work cross functionally with both internal and external business partners to process and monitor the loading of contracts Data entry and system maintenance associated with contracts within Red Oak Sourcing's internal custom applications and Microsoft Azure Data Platform Contract and formulary management ensuring alignment and coordination with both Cardinal Health and CVS Health Super User/System Administrator of content management system (Contract Logix) Identification and reporting of any system issues to our third-party consulting partner Own and manage all changes to Data Validation SOPs, communicate changes as applicable, internally and to the parent organizations Perform routine reconciliations of data feeds coming to Red Oak from Cardinal Health and CVS Health Analyze and troubleshoot issues as identified with reconciliations, and determine steps for resolution Work closely with IT to ensure daily data feeds are loaded and validated Must execute job functions in a fast-paced, dynamic environment with a high degree of accuracy Qualifications Bachelor's Degree in related field, or equivalent work experience preferred Demonstrated ability to manage multiple work streams Strong team player with solid communication skills Strong Microsoft Excel skills a plus
    $58k-77k yearly est. 15d ago
  • Lead/Project Managers - D.C

    LVI Associates 4.2company rating

    Remote or Washington, DC Job

    Senior Project Manager - Building Automation Job Type: Full-Time About the Role: We are seeking an experienced Senior Project Manager to lead and oversee building automation projects within datacenters or federal facilities. The ideal candidate will have a strong background in project management, building automation systems, and a proven track record of successfully delivering complex projects on time and within budget. Key Responsibilities: Project Leadership: Lead and manage building automation projects from initiation to completion, ensuring all project objectives are met. Stakeholder Management: Collaborate with clients, contractors, and internal teams to define project requirements, scope, and deliverables. Budget and Schedule Management: Develop and manage project budgets, schedules, and resources to ensure timely and cost-effective project delivery. Technical Oversight: Provide technical guidance and oversight for the integration and implementation of building automation systems, including HVAC, lighting, and security systems. Risk Management: Identify potential project risks and develop mitigation strategies to ensure project success. Quality Assurance: Ensure all project deliverables meet quality standards and regulatory requirements. Reporting: Prepare and present regular project status reports to stakeholders and senior management. Qualifications: Education: Bachelor's degree in Engineering, Project Management, or a related field. PMP certification is a plus. Experience: Minimum of 7 years of experience in project management, with a focus on building automation systems. Experience with datacenter or federal projects is highly desirable. Skills: Strong leadership and team management skills. Excellent communication and interpersonal skills. Proficiency in project management software and tools. In-depth knowledge of building automation systems and technologies. Ability to manage multiple projects simultaneously and prioritize tasks effectively. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Opportunities for professional development and career advancement. Flexible work environment with remote work options. How to Apply: Interested candidates are invited to submit their resume and cover letter detailing their relevant experience and qualifications.
    $92k-133k yearly est. 22d ago
  • Regulatory Affairs Associate

    Alexander Technology Group 4.3company rating

    Portsmouth, NH Job

    Alexander Technology Group is working with a Medical Device client looking to hire a Regulator Affairs Associate to join their team. in Portsmouth, NH Regulatory Affairs Associate - Combination Products We seek a detail-oriented Regulatory Affairs Associate to support New Drug Application (NDA) content development for combination products. This role focuses on regulatory documentation, compliance, and collaboration with cross-functional teams. Key Responsibilities: Draft, edit, and format NDA content for combination products. Compile and organize submission data. Conduct quality reviews for accuracy and compliance. Manage version control and document timelines. Stay updated on combination product regulations. Qualifications: Bachelor's degree in life sciences, pharmacy, engineering, or related field. Strong writing, formatting, and attention to detail. Knowledge of combination product regulations (FDA guidelines). Proficiency in document management and MS Office. Ability to work independently and in cross-functional teams. Preferred Skills: Experience in regulatory submissions or medical writing. Familiarity with eCTD, NextGen portal, and design control regulations (21 CFR Part 820).
    $56k-77k yearly est. 7d ago
  • Project Development Engineer

    Ceo Inc. 3.7company rating

    Chicago, IL Job

    The Project Development Engineer will play a key role in implementing new products and providing improvements to existing products. Responsibilities will be full scope from design to implementation for R&D initiatives and operations. Responsibilities: Design, develop, and improve new and existing products Juggle multiple projects simultaneously including new product development, compliance and testing, safety checks and approvals Apply Lean Six Sigma principles to manufacturing projects Utilization of 2D and 3D design software when required Work cross functionally with various internal departments outside of engineering such as marketing, sales, quality, supply chain and operations Work with vendors, suppliers, laboratories, and regulatory agencies as needed Requirements: Mechanical Engineering degree or equivalent Engineering degree Minimum of 3 years experience with new design and product development projects 2D and 3D design software, SolidWorks preferred Project engineering experience Strong written and verbal communication skills Ability to travel 10%
    $66k-83k yearly est. 17d ago
  • SVP, Account Services

    EPM Scientific 3.9company rating

    Remote or Virgin, UT Job

    **Job Title:** Senior Vice President (SVP), Account Services **Department:** Medical Communications - Publications and Medical Affairs A leading medical communications and healthcare marketing company dedicated to synchronizing scientific excellence with strategic and creative vision. They specialize in strategic planning, publication planning and support, and medical communications, delivering extraordinary results for their clients. **Position Overview:** Seeking an experienced and strategic Senior Vice President (SVP) to lead Account Services team within the Medical Communications department, focusing on publications and medical affairs. The SVP will play a critical role in driving client success, managing high-level client relationships, and leading a team of account professionals to deliver exceptional medical communications solutions. **Key Responsibilities:** - **Strategic Leadership:** Develop and implement strategic plans for client accounts, ensuring alignment with client objectives and industry standards. - **Client Management:** Build and maintain strong relationships with key clients, acting as a trusted advisor and ensuring high levels of client satisfaction. - **Team Leadership:** Lead, mentor, and develop a team of account managers and directors, fostering a collaborative and high-performance culture. - **Project Oversight:** Oversee the planning, execution, and delivery of medical communications projects, including scientific publications, medical affairs initiatives, and strategic communications plans. - **Business Development:** Identify and pursue new business opportunities, contributing to the growth and expansion of the medical communications team. - **Quality Assurance:** Ensure the highest standards of quality and compliance in all deliverables, adhering to industry regulations and guidelines. - **Financial Management:** Manage account budgets, monitor financial performance, and ensure profitability of client engagements. - **Industry Engagement:** Stay current with industry trends, advancements, and best practices in medical communications and publications. **Qualifications:** - Advanced degree in Life Sciences, Medicine, Pharmacy, or a related field. - Minimum of 10 years of experience in medical communications, with a focus on publications and medical affairs. - Proven track record of managing high-level client relationships and leading large teams. - Strong understanding of scientific and medical terminology. - Excellent strategic thinking, communication, and interpersonal skills. - Ability to manage multiple projects and priorities in a fast-paced environment. - Proficiency in project management tools and software. **Benefits:** - Competitive salary and performance-based bonuses. - Comprehensive health and wellness benefits. - Opportunities for professional development and career growth. - Collaborative and supportive team culture. - Flexible remote work environment. Desired Skills and Experience **Job Title:** Senior Vice President (SVP), Account Services **Department:** Medical Communications - Publications and Medical Affairs **Location:** Remote A leading medical communications and healthcare marketing company dedicated to synchronizing scientific excellence with strategic and creative vision. They specialize in strategic planning, publication planning and support, and medical communications, delivering extraordinary results for their clients. **Position Overview:** Seeking an experienced and strategic Senior Vice President (SVP) to lead Account Services team within the Medical Communications department, focusing on publications and medical affairs. The SVP will play a critical role in driving client success, managing high-level client relationships, and leading a team of account professionals to deliver exceptional medical communications solutions. **Key Responsibilities:** - **Strategic Leadership:** Develop and implement strategic plans for client accounts, ensuring alignment with client objectives and industry standards. - **Client Management:** Build and maintain strong relationships with key clients, acting as a trusted advisor and ensuring high levels of client satisfaction. - **Team Leadership:** Lead, mentor, and develop a team of account managers and directors, fostering a collaborative and high-performance culture. - **Project Oversight:** Oversee the planning, execution, and delivery of medical communications projects, including scientific publications, medical affairs initiatives, and strategic communications plans. - **Business Development:** Identify and pursue new business opportunities, contributing to the growth and expansion of the medical communications team. - **Quality Assurance:** Ensure the highest standards of quality and compliance in all deliverables, adhering to industry regulations and guidelines. - **Financial Management:** Manage account budgets, monitor financial performance, and ensure profitability of client engagements. - **Industry Engagement:** Stay current with industry trends, advancements, and best practices in medical communications and publications. **Qualifications:** - Advanced degree in Life Sciences, Medicine, Pharmacy, or a related field. - Minimum of 10 years of experience in medical communications, with a focus on publications and medical affairs. - Proven track record of managing high-level client relationships and leading large teams. - Strong understanding of scientific and medical terminology. - Excellent strategic thinking, communication, and interpersonal skills. - Ability to manage multiple projects and priorities in a fast-paced environment. - Proficiency in project management tools and software. **Benefits:** - Competitive salary and performance-based bonuses. - Comprehensive health and wellness benefits. - Opportunities for professional development and career growth. - Collaborative and supportive team culture. - Flexible remote work environment.
    $127k-194k yearly est. 10d ago
  • Founding Growth Engineer

    Impax 4.9company rating

    Santa Rosa, CA Job

    About the Role We're looking for a Founding Engineer to join an early-stage AI startup focused on building next-generation consumer experiences. This role requires a blend of engineering, product intuition, and growth-oriented thinking. You'll be instrumental in shaping the product from day one, working on cutting-edge AI applications and driving user engagement. What You'll Do: Design, build, and refine core product features using modern development tools Develop and implement AI-powered functionalities to enhance user experience Improve user acquisition, retention, and engagement through data-driven engineering Work cross-functionally with various teams to translate ideas into scalable solutions What You Bring: Strong understanding of computer science principles, whether through a degree or equivalent hands-on experience Self-motivated and eager to take ownership in a fast-paced environment Ability to break down complex problems and deliver practical, effective solutions Experience working with AI tools and automation to enhance efficiency Bonus Points For: Background in developing consumer-facing applications, particularly in interactive or AI-driven platforms Experience in growth-focused development, including experimentation and optimisation strategies Prior involvement in an early-stage startup or experience building products from scratch Tech Environment: We use a mix of modern frameworks, cloud-based infrastructure, and AI/ML technologies. A background in frontend, backend, and data management tools is useful, with familiarity in areas like JavaScript/TypeScript, backend frameworks, cloud services, and AI/ML integration. This is a high-impact role at an ambitious startup with strong early traction. If you're passionate about AI, consumer products, and growth, we'd love to hear from you!
    $109k-150k yearly est. 9d ago
  • JR00017167 Senior Software Engineer (BioDevices)

    Zoetis 4.9company rating

    Durham, NC Job

    Role Description The Senior Software Engineer is a key position in the design and advancement of BioDevices for the animal health industry. This position is responsible for the architecture, design, development, and implementation of software, supporting the creation of new commercial products and the enhancement of existing systems. Key responsibilities include designing, debugging, optimizing, and documenting software and control systems for automated equipment and research platforms. This role also involves mentoring and guiding team members, fostering a culture of innovation and technical excellence. Role Responsibilities Develop and integrate software for BioDevices, incorporating electrical controls and components, including electro-mechanical systems, pneumatic motion systems, optical sensing, signal processing, robotics, and fluid dispensing mechanisms. Establish and maintain engineering documentation standards for the development, commissioning, testing, and deployment of automation, control systems, and instrumentation solutions. Design and debug data architecture, leveraging expertise in machine control, data management, computer networking, and embedded PC hardware. Create proof-of-concept software for electrical, electronic, electro-mechanical, communication, and control systems to support research and development initiatives. Develop, code, and debug operator interfaces (HMIs), embedded controllers, and computer systems. Troubleshoot hardware-software integrations and resolve issues with HMI interfaces and related systems. Conduct trial runs of equipment, both in-house and in the field, to verify functionality and performance of control systems. Support field personnel in the operation and maintenance of the control systems for automated equipment developed by the BioDevices engineering group. Evaluate and recommend control devices, including PLCs, embedded Linux PCs or single-board computers (SBCs), operator interfaces, sensors, pneumatics, and wireless communication systems. Implement and adhere to BioDevices' software development lifecycle methodologies, ensuring robust, scalable, and maintainable solutions. Develop software requirements and specifications to address evolving market demands, customer needs, and emerging industry trends. Skill Set Requirements The new Senior Software Engineer should possess the following skills and qualifications: Technical Skills: Proficiency in programming languages such as JavaScript, C, HTML, CSS, and JQuery. Experience with Ubuntu (version 20.04 or later), including installation, shell scripting, and IOTEdge. Experience with cloud service platforms (AWS, Azure). Hands-on experience in embedded software development and software/hardware integration. Proven experience with software development life cycle (SDLC). Knowledge of DevOps practices and tools (Docker). Experience with database management systems (SQL, NoSQL) is a plus. Experience with AI, machine learning, and machine vision technologies is a plus. Understanding of cybersecurity best practices is preferred. Soft Skills: Strong problem-solving and analytical skills. Excellent communication and collaboration abilities. Ability to adapt to dynamic project requirements and deliver high-quality solutions. Ability to lead projects and mentor team members. Experience: Minimum Bachelor's Degree in Computer Science or related field. Minimum of 7-10 years of experience in software development. Proven track record of leading projects and delivering high-quality software solutions. Industry-specific experience is a plus.
    $93k-115k yearly est. 20d ago

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