Orca Bio Jobs

- 30 Jobs
  • Production Planner

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Production Planner/Scheduler is responsible for coordinating and scheduling production activities across two production sites producing clinical and commercial drug products. This role involves analyzing production specifications, capacity and resources to develop production schedules that meet customer demands and optimize production efficiency. Key Responsibilities * Assign customer orders to production slots on the manufacturing shop floor * Assign and ensure availability of materials, equipment and labor to customer orders * Utilize ERP / MES to generate manufacturing work orders * Coordinate with various teams to ensure timely manufacturing job execution and troubleshoot issues or changes to jobs * Coordinate schedule readiness and planning review meetings in review of manufacturing schedules, facility shutdowns, equipment maintenance needs and other impactful events * Tracks delivery metrics to achieve targets and customer delivery metrics * Performs capacity planning for manufacturing facilities and identifies risks, impacts and needs * Supports, as needed, Logistics management for delivery of starting material from donors and drug product materials to customers Desired Qualifications * Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize * Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment * Strong interpersonal skills and ability to communicate effectively * Strong problem-solving and critical thinking skills to support making decisions affecting due dates, quality and cost * Ability to gown and work in clean room areas from time to time * Ability to work in a collaborative manner, independently and as part of a team * Ability to work in a fast-paced start-up environment while following SOPs * Highly tolerant and respectful of all team members * A sense of humor is always appreciated * Strong problem-solving skills with desire to improve upon established processes * Ability to work for long periods of time at a computer * Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking Education and Experience * Minimum of high school diploma or GED * A.S. degree and prior work experience in healthcare. Bachelor's degree preferred * 3+ years of experience in planning and scheduling required, ideally in a manufacturing environment * Prior experience with MES and ERP systems $85,000 - $115,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. To learn more: **********************************
    $85k-115k yearly 14d ago
  • Senior Manager Training Operations

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Associate Director, Training Operations will be responsible for the design, implementation, and delivery of learning programs for Orca Bio's supply chain operations functions. This role is responsible for the strategic planning, development, implementation, and management of the training programs and training compliance for Orca Bio's cell therapy manufacturing, and related functions. The ideal candidate will bring expertise in training development cycles, instructional design, and compliance-driven training programs while ensuring that all initiatives align with industry regulations and organizational objectives. Responsibilities: * Training Program Development and Execution o Develop and implement comprehensive, role-based training curricula tailored to Orca Bio's cell therapy manufacturing. o Ensure training programs comply with GMP, FDA, EMA, and other regulatory requirements. o Oversee the development of hands-on workshops, e-learning modules, SOPs, and regulatory training content. o Collaborate with Subject Matter Experts (SMEs) to ensure training materials are accurate, relevant, and up to date. o Create and maintain training assessments and certification programs to track competencies and ensure compliance. o Drive efficiencies to improve the quality of training programs, reduce costs, optimize scalability, and enhance new employee onboarding. Training Operations & Compliance o Oversee the planning and execution of training schedules, ensuring timely and effective delivery. o Manage training logistics, including scheduling, resource allocation, and trainer coordination. o Maintain detailed training records in compliance with regulatory standards. o Ensure training programs support audits and inspections, addressing compliance gaps proactively. o Monitor training KPIs to evaluate program effectiveness and identify areas for improvement. Leadership & Continuous Improvement o Lead and develop a high-performing training team. o Foster a culture of continuous learning and operational excellence. o Stay up to date with industry best practices and emerging trends to refine training strategies. o Identify opportunities to enhance training methodologies, incorporating blended learning solutions. o Build relationships with key external partners to build and enhance training pipelines Qualifications: Technical Qualities o Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred. o Minimum of 6-10 years of experience in training and development, with at least 3 years of people leadership within the biotechnology or pharmaceutical industry. o Strong understanding of cell therapy manufacturing preferred; cGMP regulations, and compliance requirements (FDA, EMA, GxP) required. o Experience designing and implementing training programs in a complex technical pharma or biotech environment. o Proficiency in Learning Management Systems (LMS) and digital training tools. o Exceptional project management skills with the ability to manage multiple priorities. o Strong communication and collaboration skills to work cross-functionally. o Analytical mindset to assess training effectiveness and drive improvements. o Certification in training and development (e.g., CPLP, CPTM) is a plus. Personal Qualities & Work Environment o Detail-oriented, with a strong commitment to quality, compliance, and safety. o Ability to multitask and prioritize effectively in a fast-paced environment. o Strong problem-solving skills and a proactive mindset for process improvements. o Ability to work in cleanroom environments and follow GMP cleanroom protocols. o Comfortable working across various shifts when necessary. o Occasionally required to ascend/descend stairs, stand, walk, or work at a computer for extended hours. The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $128k-176k yearly est. 4d ago
  • Quality Assurance Representative

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Quality Representative position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies. Quality System Management * Oversee the management of quality systems including deviations, change controls, CAPAs, and document control. * Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions. * Review and approve change controls to ensure compliance with regulatory requirements and internal procedures. * Maintain and improve CAPA processes to ensure effective resolution of quality issues. Batch Disposition * Evaluate batch records and associated documentation to make informed batch release decisions. * Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release. * Monitor and document any quality issues related to batch production and implement corrective measures as necessary. Document Management * Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards. * Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures. Regulatory Compliance * Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance. * Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready. Training and Support * Provide training and guidance to staff on quality systems, processes, and compliance requirements. * Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization. Continuous Improvement * Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes. * Identify areas for improvement within quality operations and suggest appropriate solutions. * Track completion of quality records and maintain metrics. * Perform other duties as requested by supervisor/manager to support Quality * Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products General Requirements * Communicate effectively with team members and contribute to a positive and collaborative work environment * Actively participate in group and project teamwork; project and process improvements * Strong organizational skills and the ability to manage multiple tasks concurrently * Willingness to learn and adapt in a fast-paced, dynamic environment * Adhere to cGMP policies and procedures, including documentation activities * Able to wear appropriate personal protective equipment * Willingness to work overtime as required Desired Experience * Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5+ years of experience in quality control testing, analytical development, or GMP; OR a Master's degree in relevant scientific disciplines with 3+ years of experience * Understanding of FDA regulations, GMP compliance, and quality system processes * Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred * Able to meet project and testing timelines * Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management * Able to work collaboratively to respond to changing priorities and challenges * Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment * Prior experience doing internal audits and document control management $75,000 - $105,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $75k-105k yearly 47d ago
  • Material Handler

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary: The Material Handler ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca's cell therapy products, ensuring adherence to strict quality standards and regulatory requirements. This position involves executing processes related to warehouse materials and inventory, kitting materials for production use and managing the movement, intake and shipping of drug products and samples.Responsibilities Receive, inspect and verify incoming materials against orders and documentation Ensure materials are moved and stored in their correct locations Maintain accurate inventory records, perform cycle counts, and manage material expiration Prepare consumable materials kits for use in production Movement and transfer of materials including drug products and samples from production Maintenance of consumable gowning stock across various facility locations Receipt and incoming donor cells and shipment of patient drug productions Execution of cold storage practices and cryopreservation of drug products when needed Education & Experience Requirements Minimum of high school diploma or GED A.S. degree is preferred, but not required Experience with material management systems Experience in warehouse operations and material movements Cell and gene therapy knowledge is beneficial Personal Qualities & Physical Demands Ability to gown and work in clean rooms areas This is a shift position, working on site in Sacramento, CA, Monday through Friday from 6am to 2:30pm for first shift, Monday through Thursday from 1pm to 11:30pm for swing shift, and Monday through Thursday from 8pm to 6:30am for graveyard shift. Highly detail oriented with special attention to quality Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Ability to work in a collaborative manner Ability to work independently and as part of a team Highly tolerant and respectful of all team members A sense of humor is always appreciated Strong problem-solving skills Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Occasional need to ascend/descend stairs within work space; job requires standing/walking Ability to lift up to 50 lbs. $21 - $29 an hour The anticipated pay range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law, including shift differential pay, if applicable. You may also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $21-29 hourly 22d ago
  • Commercial Manufacturing Operator, 3rd Shift

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Manufacturing Operator plays a critical role in the production of Orca Bio's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves executing manufacturing processes, cleaning and maintaining production equipment and workstations, and documenting production activities in a highly regulated environment. This position is for 3rd shift, working on-site, Monday through Thursday 9 pm to 7:30am, at 7910 Metro Air Parkway, Sacramento, CA.Responsibilities Operate and monitor equipment used in the production of cell therapy products Follow and execute standard operating procedures (SOPs) and batch records to perform production activities Use medical grade machinery Adhere to good manufacturing practices and good documentation practices Participate and communicate effectively in a clean room manufacturing environment Perform Instrument set-up, cleaning, change over, maintenance, troubleshooting, and operation Education & Experience Requirements Minimum of high school diploma or GED A.S. degree is preferred, but not required Prior experience in GMP manufacturing, lab scale manufacturing preferred Cell and gene therapy knowledge is beneficial Personal Qualities & Physical Demands Ability to gown and work in clean rooms and Biosafety safety cabinets Highly detail oriented with special attention to quality Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Ability to work in a collaborative manner, independently and as part of a team Highly tolerant and respectful of all team members A sense of humor is always appreciated Strong problem-solving skills Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Occasional need to ascend/descend stairs within work space; job requires standing/walking $21 - $29 an hour The anticipated pay range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law, including shift differential pay, if applicable. You may also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $21-29 hourly 60d+ ago
  • Head of Legal

    Orca Bio 4.1company rating

    Orca Bio Job In Menlo Park, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary As the company's first legal hire, the Head of Legal (Director/Sr. Director level) will play a key role in supporting Orca Bio's growth and development. The ideal candidate will have 7-10 years of corporate and/or transactional law experience in the life sciences industry, and will have served as both in-house counsel at a company and as outside counsel at a top-tier law firm. The Head of Legal will be responsible for providing legal counsel and support to Orca Bio on a wide range of matters, including corporate governance, strategic and financing transactions, contract operations and review, clinical trials, employment, regulatory compliance, and commercial preparedness. If you are a highly motivated corporate attorney who is interested in a challenging and rewarding opportunity, we encourage you to apply for this position. ResponsibilitiesAdvise the Company on strategic and financing transactions, including managing due diligence, drafting and negotiation of transaction documents, and closing Draft, review, and negotiate general and sophisticated corporate and commercial agreements, including licenses, manufacturing, confidentiality, material transfer, consulting, employment, vendor, services, purchasing, outsourcing, software, research, licensing, clinical trial, and data-related agreements Advise the Company on regulatory compliance matters, including FDA regulations, HIPAA regulations, and export controls Represent the Company in regulatory proceedings and litigation Provide general advice and guidance on legal best practices as we approach product approval / launch Efficiently source, manage, and direct outside counsel Required QualificationsJD degree from an accredited law school7-10+ years of experience in corporate law Current admission to any state bar in good standing (California preferred) Life Science industry experience Experience with strategic and financing transactions, including IPO, equity, and/or M&A Preferred QualificationsExperience working in-house at a small or mid-sized biotechnology company Experience at a company progressing from clinical stage through commercialization Experience working for a top-tier law firm Experience with FDA regulations The anticipated annual salary range for this job is $200,000 - $275,000, based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $80k-139k yearly est. 22d ago
  • Senior Safety Scientist

    Orca Bio 4.1company rating

    Remote Orca Bio Job

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Senior Safety Scientist will help develop and strengthen the safety science group by supporting drug safety and risk management activities across Orca Bio's clinical programs. ResponsibilitiesSupport signal detection, evaluation and management, including conducting aggregate data analysis and case level review, and creating presentations in assigned programs or studies Assist in the development of risk management strategy and activities for both pre- and post-marketed programs, including providing content for RMPs, evaluating risk minimization activities and preparing responses for regulatory authority safety requests Support safety in clinical trials with review of protocols, SAPs, ICFs and other clinical documents Lead the planning, preparation, writing and review of periodic safety reports (eg, DSUR, PSUR, PBRER) in accordance with regulatory requirements Review AEs/AESIs from clinical trials and provide input on TFLs, listings and other biometrics outputs Collaborate cross-functionally, representing the PV function in the study team matrix Support the conduct and operation of safety governance, including internal and external safety committees Conduct literature review for assigned programs Support activities related to regulatory filings Support analysis of safety data and writing of safety sections for documents such as CSRs, CSR patient narratives, IBs, RMPs, Summary of Clinical Safety, ISS, and labeling Support inspection preparedness activities and complete any post audit/inspection deliverables within required timelines Stay abreast of changes in regulations, supporting updates to SOPs QualificationsAdvanced degree in a biologic/medical/clinical/nursing field, such as Pharmacist/PharmD, RN/NP, or PhD.Minimum of 3-5 years of experience in the biotech/pharmaceutical industry with at least 3 years of experience in drug safety, safety science and risk management Knowledge of US and EU pre- and post-marketing pharmacovigilance requirements. Experience with analysis of safety data from clinical and safety databases Proficiency in preparing pre-marketing (eg, investigational) and post marketing safety regulatory documents, including DSURs, PSURs and RMPs. Experience with clinical development, risk/benefit analysis, and signal detection.Strong clinical, analytical, problem-solving, scientific writing, and communication skills.Hands-on mentality, ability to operate with limited resources. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $86k-130k yearly est. 1d ago
  • Training Coordinator

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Training Coordinator is responsible for facilitating the day-to-day operation of the training systems, including training files and records, curriculum assignments and tracking, reporting and scheduling of training activities. This role supports Good Manufacturing Practices (GMP) related to training in Orca clinical and commercial organization. The training coordinator works closely with quality, planning and manufacturing to ensure compliance with regulatory standards. Responsibilities * Maintain accurate training records and files of all training activities, certifications and employee process * Manage the assignment, creation and removal of employee training curriculum in the Training System * Maintain a job code matrix in line with requirements for various employee positions * Facilitate the creation of job codes that include the appropriate learning content of standard operating procedures, work instructions, certifications * Prepare and distribute training reports, including compliance metrics and follow up on actions needed to maintain compliance * Scheduling and tracking of training sessions to ensure employees receive required GMP trainingin a timely manner * Support employee training sessions as required Education & Experience Requirements * High school diploma or equivalent required * Associate's degree or certifications in training strongly preferred * 2-3 years of experience in manufacturing related operations, in biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries * Experience with on-the-job training, or training systems a plus * Prior experience in regulated, GMP manufacturing operations is a plus * Strong communication and problem-solving skills, organizational skills Personal Qualities & Physical Demands * Highly detail oriented with special attention to quality, compliance and safety * Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize * Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment * Strong interpersonal skills and ability to communicate effectively * Ability to work in a collegial and collaborative manner, independently and part of a team * Ability to work in a fast-paced start-up environment while following SOPs * Highly tolerant and respectful of all team members * Strong problem-solving skills with desire to improve upon established processes * Ability to gown into cleanrooms and follow clean room protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition * Physical demands include standing, walking and working at a desk $55,000 - $75,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $55k-75k yearly 39d ago
  • Warehouse Coordinator

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Warehouse Coordinator is responsible for facilitating the day-to-day operation in the warehouse, ensuring accurate inventory management, coordinating the movement of goods and ensuring materials are supplied efficiently to manufacturing operations. This role works closely with quality, planning and manufacturing to ensure product quality, efficiency and compliance with regulatory standards. Key Responsibilities * Coordinate the receiving, storing, and distribution of products and materials in the warehouse. * Maintain accurate inventory records through regular stock counts and audits. * Monitoring inventory levels to ensure timely replenishment and prevent stockouts. * Ensure proper labeling and documentation of all products in the warehouse. * Resolve any discrepancies between physical inventory and system records. * Facilitating daily operations of the warehouse, ensuring that goods are stored in an organized and efficient manner. * Coordinate the picking, packing, and shipping of orders to customers or other departments. * Ensure compliance with safety standards and maintain a clean and organized warehouse environment. * Manage the allocation of resources such as staff, equipment, and materials to optimize. * Coordinate inbound and outbound shipments, ensuring accurate documentation and timely delivery. * Work with carriers and suppliers to schedule deliveries and resolve shipping issues. * Inspect incoming goods for damage or defects and ensure appropriate actions are taken. * Use warehouse management systems or ERP systems to track inventory and manage orders. * Ensure data accuracy in the system for inventory levels, order processing, and shipping. * Generate and maintain reports related to inventory, order status, and warehouse activities. Education & Experience * High school diploma or equivalent required. * Associate's degree or certifications in logistics or supply chain management strongly preferred2-3 years of experience in warehouse operations preferably in biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries. * Experience with warehouse management systems or inventory software is a plus. * Prior experience in regulated, GMP manufacturing operations is a plus. * Strong communication and problem-solving skills, organizational skills, forklift certification and lean principles a plus. Personal Qualities & Physical Demands * Highly detail oriented with special attention to quality, compliance and safety. * Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively. * Ability to work in a collegial and collaborative manner, independently and part of a team. * Ability to work in a fast-paced start-up environment while following SOPs. * Highly tolerant and respectful of all team members. * Strong problem-solving skills with desire to improve upon established processes. * Ability to gown into cleanrooms and follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition. * Physical demands include standing for extended periods, lifting moderate weights up to 50 lbs, moving goods around the warehouse and occasional need to ascend/descend stairs. $21 - $29 an hour The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $21-29 hourly 39d ago
  • Clinical Research Associate

    Orca Bio 4.1company rating

    Remote Orca Bio Job

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary: In this contract CRA role, you will be responsible for monitoring the progress of clinical studies (primarily, our phase 3 Precision-T study), either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. You can be based anywhere in the U.S., although west coast is preferred. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring. Responsibilities:Conduct interim monitoring visits (IMVs) and ISF review Review electronic medical records (EMR)/patient data Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol Provide support to site staff including research coordinators and physicians Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides) Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates Desired Qualifications:BA/BS or equivalent with a minimum of 3+ years of relevant clinical trial management experience Therapeutic experience in oncology/hematology and cell and gene therapy preferred Prior CRA experience working directly for sponsor, ideally a start-up/or small company, in a co-monitoring capacity Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures Experience with Trial Master File management according to the DIA reference model Experience operating within various site EMR/EHR systems Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals Personal Qualities:Highly detail oriented with special attention to quality and quality control Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Well organized and able to work under tight deadlines Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills, including verbal and written communication, are essential Ability to work in a collegial and collaborative manner; independently and as part of a team Ability to work in a fast-paced and informal startup environment Highly tolerant and respectful of all members of our team Strong problem-solving skills with desire to improve upon established processes Sense of humor Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $51k-80k yearly est. 1d ago
  • Quality Management System (QMS) Administrator - MasterControl

    Orca Bio 4.1company rating

    Remote Orca Bio Job

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We are seeking a highly motivated and experienced Quality Management System (QMS) Administrator with in-depth expertise in using MasterControl to join our team. This role is integral to maintaining and optimizing the company's quality management processes, ensuring compliance with industry standards and regulations, and supporting continuous improvement initiatives. The QMS Administrator will work closely with cross-functional teams to manage the MasterControl platform, handle document control, change control, audits, metric development, report development and ensure smooth operations within the quality management system. Key ResponsibilitiesMasterControl Administration: Manage, maintain, and optimize the MasterControl QMS platform to support quality processes across the organization. This includes configuring user access, workflows, and system settings.Document Control: Oversee document management processes within MasterControl, ensuring that all documents are accurately categorized, reviewed, approved, and updated in compliance with regulatory standards.Training: Provide training to employees on MasterControl and QMS best practices. Support the onboarding process for new team members and ensure they understand the system's functionalities.Compliance Support: Ensure adherence to regulatory standards (such as ISO 9001, FDA, or GMP) and internal policies by managing and monitoring the QMS activities through MasterControl.Audit Preparation & Support: Prepare for and assist during internal and external audits. Ensure MasterControl records are accurate, up-to-date, and ready for audit reviews.System Troubleshooting: Act as the go-to point of contact for troubleshooting MasterControl issues, collaborating with the IT team or MasterControl support when necessary.Continuous Improvement: Identify opportunities to streamline and improve QMS processes within MasterControl. Suggest and implement process improvements to enhance overall system effectiveness.Reporting & Analytics: Generate and analyze reports from MasterControl to monitor the performance of the QMS and provide insights to senior management on key metrics.Cross-Functional Collaboration: Work with various departments (e.g., R&D, Operations, Regulatory, and Compliance) to ensure QMS processes are aligned with organizational goals and standards.Change Management: Manage change control processes within MasterControl, ensuring that changes to systems, processes, or documents are well-documented, approved, and implemented according to established protocols. QualificationsExperience: Minimum of 3 years of experience in quality management system administration, with at least 2 years of hands-on experience using MasterControl.Technical Skills: In-depth knowledge of MasterControl platform, including configuration, workflows, document control, and training modules.Certifications: ISO 9001, FDA, GMP, or other relevant quality certifications are a plus.Analytical Skills: Strong ability to analyze data and create detailed reports and metrics.Attention to Detail: High level of attention to detail and accuracy in managing QMS documentation and workflows.Problem Solving: Strong troubleshooting skills, particularly in QMS-related issues within MasterControl.Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact with cross-functional teams.Education: Bachelor's degree in Quality Management, Engineering, Life Sciences, or related field preferred. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $68k-93k yearly est. 1d ago
  • Vice President, Medical Affairs

    Orca Bio 4.1company rating

    Orca Bio Job In Menlo Park, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary: The Vice President of Medical Affairs will report to our Chief Medical Officer. You will build, develop, and lead our newly formed Medical Affairs function including Medical Science Liaisons, Medical Affairs Operations, Medical Information, Medical Communications, and Investigator Sponsored Trials for Orca-T (our lead, late-stage product), and other products in development as needed (responsibility shared with the Clinical R&D team for products in development). You will lead the medical affairs team while working closely with the R&D team to support the publication and promulgation of clinical/pre-clinical data as well as other important information. You will present a strong outward-facing presence with key KOLs and will support the company in many different capacities, including business development. You will provide medical support for our lead registrational trial, Precision-T , a randomized phase III trial of patients with Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation with either Orca-T, a T-cell-Depleted Graft with additional infusion of Conventional T cells and Regulatory T cells, or Standard-of-Care Allogeneic Graft.Key Responsibilities Accountable for the leadership, development, and execution of the Medical Affairs Strategy-including the design and structure to support the necessary supporting functions of a Medical Affairs team such as Med Info, Med Com, Pub planning, MSLs, etc., allocating and directing internal resources while effectively utilizing outsourcing to achieve project and business goals in a timely manner. Provide scientific and functional leadership to the future Medical Affairs team. Develop and lead Key Opinion Leader outreach by establishing and maintaining strong relationships with key opinion leaders, academic institutions, and medical societies in the field of hematology/oncology, particularly cell therapy. Assess sizing needs and implement a field facing MSL team. Lead publication strategy and planning, CME education, symposia, and congress planning and assess full Medical Communication requirements to support launch. Assess and implement Medical Information requirements to support launch. Establish investigator-initiated studies program review process post-launch Establish policies and procedures for key Medical Affairs activities, ensuring compliance with the principles of Scientific Engagement, including leading discussions around compassionate use programs Lead the medical strategy for Advisory Board meetings. Work closely with the Regulatory and Commercial organizations to ensure timely, accurate and compliant preparation and review of promotional and educational material. Partner with Legal and Compliance to ensure Medical Affairs activities are conducted according to Orca's policies and procedures, and in a manner compliant with all external laws and regulations. Collaborate closely with cross-functional teams, including clinical development, clinical operations, project management, regulatory affairs, and commercial, to drive the successful development and commercialization of Orca-T. Provide medical and scientific training to the rest of the organization, and as well as, guidance to Commercial/Marketing Organizations on promotional material and campaigns. Help define and lead strategy as a senior member of the research and development organization and be a member of the Research and Development leadership team. Qualifications Educational requirements: Advanced life science degree, including M.D., Ph.D., N.P, and/or Pharm.D. Minimum of 12 years' medical affairs or clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned). Minimum of 5 years' experience in leading a Medical Affairs function; prior experience with new product launch strongly preferred. Previous Medical Affairs expertise within hematology and/or transplant experience (specific diseases include AML, ALL, MDS) strongly preferred. Previous cell therapy experience highly desirable. Track record of success in building and leading teams. Collaborative Medical leader who can establish and drive strong cross-functional partnerships and scientific exchange with diverse stakeholders. Experience in the US health care marketplace is required. Extensive travel is required as part of this position (up to 50%). Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $140k-211k yearly est. 11d ago
  • Scientist, Flow Cytometry

    Orca Bio 4.1company rating

    Orca Bio Job In Menlo Park, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The flow cytometry scientist will join the CMC team and work cross-functionally with several departments (R&D, Process Development, Analytical Development, Quality Control) as the subject matter expert for the development, qualification and maintenance of the flow cytometry-based assays for Orca Bio's cell therapy-based drug products. This role includes development and execution of lab-based studies and hands-on training of scientists in specific methods, troubleshooting methods, assuring methods developed by are robust and ready. Additionally, the role will be involved in overseeing method transfers into the GMP operations. The flow cytometry scientist will participate in writing documentation for regulatory filings. The candidate must be independent, project-oriented, timeline-driven, and able to efficiently work across multiple departments. The position is focused on enhancing the use of flow cytometry assays and assuring flow assay development, transfer to QC, and validation results in robust GMP capable flow assays. ResponsibilitiesDesign and execute lab-based studies to develop and enhance flow-based assays for cell therapy products Support method development, qualification and validation studies for flow cytometry assays Manage transfer activities to ensure method readiness for manufacturing and product release Teach and train other scientists in flow cytometry and other cell-based assays Author and review laboratory specific processes and procedures as well as technical documents such as methods, qualification/validation protocols, reports, and CMC sections for regulatory filings Participate in the investigation and resolution of Out of Specification investigations QualificationsBS Degree in immunology, cellular and molecular biology, biological sciences, or a closely related field; PhD preferred Experience in developing flow cytometry assays; minimum 5 years specifically in flow cytometry Advanced educational background can substitute for industry experience Knowledge of GMP regulations is a plus Excellent attention to detail, organizational skills, and ability to multi-task in a dynamic environment Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $107k-168k yearly est. 15d ago
  • People Business Partner

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built our own centralized 100,000 square foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure consistent and reliable delivery of our high-precision cell therapies. Our state-of-the-art facility represents critical infrastructure to enable the clinical advancement of our pipeline and the future commercial availability of our potentially life-saving products. Reporting into our Head of People, The People Business Partner serves as a trusted advisor to site leadership at Orca Bio's Sacramento operations-translating business strategies into effective people initiatives. You will work closely with the People Team to ensure that Orca Bio's principles and policies are consistently upheld across the sites. This role is a blend of strategic vision and hands-on execution, driving a high-performance culture, enhancing employee engagement, and optimizing People processes in alignment with our long-term business goals.Key Responsibilities Strategic Partnership & Business Alignment: Collaborate with senior leaders and business groups to understand site-specific strategies, organizational plans, and performance targets. Diagnose organizational needs and recommend tailored People solutions and resources that support business objectives. Serve as a strategic consultant, ensuring that People initiatives are integrated into the company's decision-making and long-term planning. Culture, Engagement & Change Management: Continually assess the site's culture and employee engagement levels; proactively identify issues and implement solutions to boost engagement and retention. Act as a change agent by challenging the status quo and introducing best practices to mitigate talent challenges before they impact business performance. Develop and deploy comprehensive employee engagement programs-from onboarding new team members to ongoing initiatives that foster an inclusive, high-performance. Talent & Performance Management: Develop, manage, and execute integrated People solutions around compensation planning, talent management, performance reviews, and talent acquisition. Oversee the coordination of key People processes, such as annual performance reviews and salary planning-including scheduling, conducting training sessions, and reporting outcomes. Identify, nurture, and develop high-potential employees to build a robust pipeline of future leaders who will drive business growth and success. Operational Excellence & Process Improvement: Ensure all site People processes are consistent with company policies, industry best practices, and legal requirements. Utilize People metrics and data analysis to identify trends, uncover areas for improvement, and implement data-driven solutions that enhance organizational effectiveness. Collaborate on the development and execution of workforce plans, career path strategies, and employee retention initiatives to elevate overall talent strength. Communication, Guidance & Education: Serve as the primary resource for managers and employees by providing timely, tailored People guidance, coaching, and education across all levels of the organization. Partner with business leaders to support effective team building and organizational development through coaching on performance management and employee development. Act as the voice of the customer for the People & Culture team, ensuring that frontline feedback is integrated into the continuous improvement of People processes. Key Skills & Experience 8+ years of progressive People experience, with a strong background in recruitment, talent management, compensation planning, performance management, and employee engagement within a manufacturing and operational environment at a biotech/pharmaceutical company. Demonstrated expertise in strategic People partnership and change management, with a proven ability to analyze People metrics and drive improvements through data-driven decision-making. Exceptional interpersonal skills and a track record of building trusted, collaborative relationships with senior leaders and cross-functional teams. In-depth knowledge of People best practices, policies, and legal requirements to ensure compliance and operational excellence. Bachelor's degree or equivalent in Human Resources, Business, or a related field. Personal Attributes A proactive, hands-on leader with the ability to “read the pulse” of the organization and drive meaningful change. Adaptable and comfortable navigating ambiguity in a fast-paced, evolving environment. A creative problem-solver with impeccable organizational skills, strong time management, and a results-oriented mindset. An excellent communicator capable of articulating complex issues clearly and influencing diverse stakeholders. Why Join Orca Bio? Play a vital role in driving the success of our business by aligning People processes with strategic objectives. Enjoy a position that offers a blend of strategic oversight and hands-on execution in a dynamic biotech environment. Work with a collaborative People Team dedicated to fostering a culture of excellence, continuous improvement, and innovation. $125,000 - $150,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $125k-150k yearly 15d ago
  • (Sr.) Manager, Facilities

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The (Sr.) Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating all utility systems (HVAC, electrical, purified water, compressed air, plumbing, etc.), managing service providers (cleaning, pest control, waste disposal, etc.), maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will also work closely with other teams to support the overall goals of the organization.Responsibilities Facility Operations & Maintenance: Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, electrical, purified water, compressed air, plumbing, etc.). Develop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant. Collaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment. Ensure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks. Manage vendor relationships for services such as cleaning, pest control, maintenance and calibration services, ensuring delivery of quality services and compliance with service agreements. Health, Safety & Compliance: Ensure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes). Participate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts. Budget Management: Support development and management of the facility's operational and maintenance budget, controlling costs related to maintenance, repairs and outside services. Project Management: Plan and coordinate facility-related projects such as improvements or expansions. Manage projects related to the installation of new equipment. Work with other departments and external contractors and vendors to ensure successful project execution. Qualifications Education: Bachelor's degree in Facility Management, Engineering, or a related field preferred. Experience/Skills: 5-7 years (Manager) or 7-10 years (Sr. Manager) of experience in facilities management in a GMP environment. Experience in the biotechnology/pharmaceutical industry required. Strong knowledge of building systems (HVAC, purified water, compressed air, plumbing, electrical), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry. Excellent leadership, communication, and interpersonal skills. Experience/proficiency with maintenance management software and systems. Excellent project and time management skills with the ability to oversee multiple tasks at once. Budgeting experience. Problem-solving and troubleshooting, and ability to make sound decisions. The position requires on-site presence and typically involves regular office hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $74k-119k yearly est. 6d ago
  • MSAT (Associate) Director

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The MSAT (Associate) Director is responsible for leading the Manufacturing Science and Technology team within the Orca organization. This role oversees manufacturing processes as they transfer from development into commercial operations and throughout the commercial lifecycle of the product. The MSAT (Associate) Director works closely with teams, such as Development, Quality, Operations, Regulatory Affairs and Chemistry and Manufacturing Controls to launch, scale-up and optimize operational attributes to ensure product quality, efficiency and compliance with regulatory standards. This position requires on-site attendance at our Sacramento facility.Responsibilities Lead a team of scientists, engineers and technical experts to support the launch, scale up and maintenance of late stage and commercial manufacturing processes Establish and maintain performance metrics to measure manufacturing operations. Develop strategies to enhance manufacturing processes, including optimizing processes for investigation, corrective actions and change management for MSAT Projects Implement process improvements based on data analysis and scientific principles including focus on technology, alternate materials, shipping and labeling, and data from continuous process verification Drive the execution of various studies, qualifications and design of experiments related to deviations, process performance, and regulatory needs for commercial products. Develop and drive practices for the transfer of processes from development into commercial manufacturing facilities Coordinate with the operations team to ensure successful implementation of new processes in commercial GMP environments Collaborate with cross functional teams to trouble shoot and resolve technical issues Lead and drive the preparation and review of data to support regulatory submissions Build and mentor the MSAT team ensure the team is equipped with the skills and tools to meet current and future manufacturing needs Education & Experience Requirements B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required PhD in Chemical Engineering, Biochemistry or Analytical Chemistry is preferred Associate Director: Minimum of 8 years of relevant experience Director: Minimum of 10 years of experience, with demonstrated success in higher-level decision-making roles Experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries 4+ years of people leadership experience Prior experience in regulated, GMP manufacturing operations Strong communication and problem-solving skills Experience in Cell therapy manufacturing preferred Knowledge of automation, continuous process verification, investigation processes, process optimization Personal Qualities & Physical Demands Highly detail oriented with special attention to quality, compliance and safety Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Ability to work in a collegial and collaborative manner, independently and part of a team Ability to work in a fast-paced start-up environment while following SOPs Highly tolerant and respectful of all team members Strong problem-solving skills with desire to improve upon established processes Ability to work in cleanroom environments and, at times, across various shifts Ability to follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Occasional need to ascend/descend stairs within workspace; job requires standing/walking The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $108k-167k yearly est. 6d ago
  • Commercial Manufacturing Operator, 2nd Shift

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Manufacturing Operator plays a critical role in the production of Orca Bio's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves executing manufacturing processes, cleaning and maintaining production equipment and workstations, and documenting production activities in a highly regulated environment. This position is for 2nd shift, working on-site, Monday through Friday from 3pm to 11:30pm, at 7910 Metro Air Parkway, Sacramento, CA.Responsibilities Operate and monitor equipment used in the production of cell therapy products Follow and execute standard operating procedures (SOPs) and batch records to perform production activities Use medical grade machinery Adhere to good manufacturing practices and good documentation practices Participate and communicate effectively in a clean room manufacturing environment Perform Instrument set-up, cleaning, change over, maintenance, troubleshooting, and operation Education & Experience Requirements Minimum of high school diploma or GED A.S. degree is preferred, but not required Prior experience in GMP manufacturing, lab scale manufacturing preferred Cell and gene therapy knowledge is beneficial Personal Qualities & Physical Demands Ability to gown and work in clean rooms and Biosafety safety cabinets Highly detail oriented with special attention to quality Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Ability to work in a collaborative manner, independently and as part of a team Highly tolerant and respectful of all team members A sense of humor is always appreciated Strong problem-solving skills Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Occasional need to ascend/descend stairs within work space; job requires standing/walking $21 - $29 an hour The anticipated pay range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law, including shift differential pay, if applicable. You may also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $21-29 hourly 60d+ ago
  • Training Coordinator

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA Or Remote

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Training Coordinator is responsible for facilitating the day-to-day operation of the training systems, including training files and records, curriculum assignments and tracking, reporting and scheduling of training activities. This role supports Good Manufacturing Practices (GMP) related to training in Orca clinical and commercial organization. The training coordinator works closely with quality, planning and manufacturing to ensure compliance with regulatory standards.Responsibilities Maintain accurate training records and files of all training activities, certifications and employee process Manage the assignment, creation and removal of employee training curriculum in the Training System Maintain a job code matrix in line with requirements for various employee positions Facilitate the creation of job codes that include the appropriate learning content of standard operating procedures, work instructions, certifications Prepare and distribute training reports, including compliance metrics and follow up on actions needed to maintain compliance Scheduling and tracking of training sessions to ensure employees receive required GMP trainingin a timely manner Support employee training sessions as required Education & Experience Requirements High school diploma or equivalent required Associate's degree or certifications in training strongly preferred 2-3 years of experience in manufacturing related operations, in biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries Experience with on-the-job training, or training systems a plus Prior experience in regulated, GMP manufacturing operations is a plus Strong communication and problem-solving skills, organizational skills Personal Qualities & Physical Demands Highly detail oriented with special attention to quality, compliance and safety Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Ability to work in a collegial and collaborative manner, independently and part of a team Ability to work in a fast-paced start-up environment while following SOPs Highly tolerant and respectful of all team members Strong problem-solving skills with desire to improve upon established processes Ability to gown into cleanrooms and follow clean room protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Physical demands include standing, walking and working at a desk $55,000 - $75,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $55k-75k yearly 8d ago
  • Production Planner

    Orca Bio 4.1company rating

    Orca Bio Job In Sacramento, CA

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Production Planner/Scheduler is responsible for coordinating and scheduling production activities across two production sites producing clinical and commercial drug products. This role involves analyzing production specifications, capacity and resources to develop production schedules that meet customer demands and optimize production efficiency.Key Responsibilities Assign customer orders to production slots on the manufacturing shop floor Assign and ensure availability of materials, equipment and labor to customer orders Utilize ERP / MES to generate manufacturing work orders Coordinate with various teams to ensure timely manufacturing job execution and troubleshoot issues or changes to jobs Coordinate schedule readiness and planning review meetings in review of manufacturing schedules, facility shutdowns, equipment maintenance needs and other impactful events Tracks delivery metrics to achieve targets and customer delivery metrics Performs capacity planning for manufacturing facilities and identifies risks, impacts and needs Supports, as needed, Logistics management for delivery of starting material from donors and drug product materials to customers Desired Qualifications Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills and ability to communicate effectively Strong problem-solving and critical thinking skills to support making decisions affecting due dates, quality and cost Ability to gown and work in clean room areas from time to time Ability to work in a collaborative manner, independently and as part of a team Ability to work in a fast-paced start-up environment while following SOPs Highly tolerant and respectful of all team members A sense of humor is always appreciated Strong problem-solving skills with desire to improve upon established processes Ability to work for long periods of time at a computer Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking Education and Experience Minimum of high school diploma or GED A.S. degree and prior work experience in healthcare. Bachelor's degree preferred 3+ years of experience in planning and scheduling required, ideally in a manufacturing environment Prior experience with MES and ERP systems $85,000 - $115,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. To learn more: **********************************
    $85k-115k yearly 12d ago
  • Head of Field U.S. Market Access

    Orca Bio 4.1company rating

    Remote Orca Bio Job

    More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Head of Field US Market Access will report to the VP of Global Market Access. In this role, you will build and lead a US Payer Field Team of Account Directors, who will be responsible for delivering patient access and removing access barriers, which ultimately results in revenue and profitability that is aligned to Orca-T's budget. You will provide strategic leadership to ensure Orca-T is positioned to maximize market access potential and profitability across all market segments. You will lead the payer marketing strategy, product value proposition, and the development of the tactical plan to support launch activities. Finally, you will will finalize launch plans, tactics, and metrics as well as lead both the internal and external access disease education strategy. Key ResponsibilitiesProvide strategic leadership to ensure specific market access, value insights and perspectives are integrated and activated in action plans across the brand launch and life cycle management objectives.Function as primary resource to assess and evaluate macro trends in the healthcare environment that potentially impact product pricing, contracting and associated strategies.Direct and execute value-based pricing strategies Orca-T and its indications inclusive of analyses, payer reimbursement and if needed contract/discount strategies while considering the patient/customer experience.Support (with Commercial Operations as lead) interface with Finance to develop forecasting and revenue recognition models for evaluation of WAC/NET/GTN.Build engagement strategies to inform and prepare the market both pre and post launch to deliver the brand value proposition to ensure patient access.Conduct payer market research and tactic creation in partnership with the Brand team to communicate strategic imperatives and optimize value of products.Lead market access data analytics programs and KPI evaluation.In conjunction with Medical/HEOR teams, work to develop long-range strategies and tactics to understand the evolution of payer evidence needs.Develop, revise and maintain assigned branded and non-branded account management resources to facilitate and accelerate access and brand growth.Recruit, develop and retain a high performing team and establish a results-driven, customer-focused and team-centered culture.Develop and manage operational budgets consistent with corporate financial goals.Ensure compliance with corporate policies and procedures, as well as US Healthcare laws and regulations. QualificationsCollege degree with MBA preferred and 10+ years or relevant experience, including leading high performing payer teams.Comprehensive knowledge and understanding of US Healthcare system and reimbursement challenges and opportunities.In-depth functional knowledge across market access, pricing and contracting, life cycle management and patient services integration within team.Strong understanding of financial analytics and forecast development.Customer-centric approaches with sustainability and scalability.Understanding of commercialization process, reimbursement integration points and clinical development processes.Commercial experience (Marketing and Sales), product launch and pricing experience in the US.Working knowledge of market access, patient access and support services, pricing and contracting approaches.Previous cell therapy experience.Travel as required. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
    $43k-63k yearly est. 1d ago

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Orca Bio may also be known as or be related to Orca Bio, Orca Biosystems Inc and Orca Biosystems, Inc.