Supervisor, Quality Control Biology

Duties/Responsibilities

• Write and revise SOPs/Test methods that support Artiva’s cell therapy products.
• Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Serve as primary QC Biology point of contact for cross-functional teams including Manufacturing, QA, and Regulatory Affairs for release and investigation activities.
• Lead training and qualification of Bio team members on equipment use and biological test methods.
• Support activities for QC equipment IQ/OQ/PQs.
• Lead and perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
• Lead evaluation of QC systems and/or implementation of system improvements.
• Perform laboratory investigations and write reports for deviations.
• Ensure data integrity practices (ALCOA+ principles) are followed by the Bio team; support LIMS/ELN implementation and administration as applicable.
• Assist in laboratory investigations for Out of Specification results.
• Aid in biological method qualification and validation as needed.
• Perform periodic trending of QC testing data; identify adverse trends and initiate CAPAs as appropriate.
• Plan and schedule for GMP in-process and release testing.
• Review biology data and investigate OOS and OOT results.
• Write technical QC protocols and reports as needed.
• Aid QC and AD team for analytical qualification and validation, as necessary.
• Develop an in-depth understanding of NK and CAR-NK products, testing, and safety.
• Maintain records and databases in accordance with procedures.

  Qualifications

  • Bachelor’s degree (BS/BA) in Biology, Biochemistry, Immunology, or a related life science field required.
  • Experience with NK cell or CAR-modified cell therapy products preferred; familiarity with viability, cytotoxicity, identity, and potency assays for cell therapy products.
  • Minimum 8 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
  • At least 1 year of Supervisory or team lead experience is required.
  • Knowledge and experience in supporting cGMP deviations, OOS, etc.
  • Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application.
  • Excellent critical thinking and technical writing skills.
  • Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs.

    Pay

    Base Salary: $ 110,000 - $135,000. Exact compensation may vary based on level, skills and experience.