Artiva Biotherapeutics

Supervisor, Quality Control Biology

Artiva Biotherapeutics$110K — $135K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biology, Biochemistry, Immunology, or related life science required.
  • 8+ years of cGMP QC experience in cell therapy or biotech settings.
  • 1+ year of supervisory or team lead experience required.
  • Familiarity with NK cell or CAR-modified cell therapy products preferred.
  • Knowledge of supporting cGMP deviations and OOS activities is essential.
  • Strong critical thinking and technical writing skills are necessary.
  • Proficient with Microsoft Office Suite including Word, Excel, and Project.

Responsibilities

  • Write and revise SOPs and test methods for cell therapy products.
  • Operate analytical instruments like ELISA and flow cytometers as needed.
  • Act as primary QC Biology contact for cross-functional interactions.
  • Lead training and the qualification of team members on relevant equipment and methods.
  • Perform routine cGMP release and stability testing of products.
  • Lead evaluations and improvements of QC systems as required.
  • Ensure adherence to data integrity practices within the team.

Benefits

  • Comprehensive Medical, Dental, and Vision coverage.
  • Group Life Insurance for employee protection.
  • Long-Term Disability coverage.
  • 401(k) Retirement Plan for future savings.
  • Employee Assistance Program (EAP) for personal support.
  • Flexible Spending Account (FSA) for healthcare expenses.
  • Generous Paid Time Off (PTO) policy.
  • Company paid holidays, including a week off at year-end.
  • Recognition program with Bonus.ly for rewarding achievements.
Full Job Description
Job Summary: Artiva Biotherapeutics is seeking a skilled and motivated Quality Control Supervisor who will be reporting to the Senior Manager, Quality Control. This individual will supervise the Bio Team and support QC biology testing. The individual will additionally perform routine cGMP release and stability testing of Artiva's products. 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. - Assist in biological method qualification and validation as needed. - Perform periodic trending of QC testing data; identify adverse trends and initiate CAPAs as appropriate. - Perform all work according to company policies, SOPs, and cGMP practices. - Planning and scheduling for GMP in-process and release testing. - Reviewing biology data and investigating OOS and OOT results. - Write technical QC protocols and reports as needed. - Assist 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. In addition to a great culture, we offer: - A beautiful facility - An entrepreneurial, highly collaborative, and innovative environment - Comprehensive benefits, including: - Medical, Dental, and Vision - Group Life Insurance - Long Term Disability (LTD) - 401(k) Retirement Plan - Employee Assistance Program (EAP) - Flexible Spending Account (FSA) - Paid Time Off (PTO) - Company paid holidays, including the year-end holiday week - Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. Base Salary: $ 110,000 - $135,000. Exact compensation may vary based on level, skills and experience.

About Artiva Biotherapeutics

Artiva Biotherapeutics is a clinical-stage biotechnology company developing a pipeline of novel, precisely targeted immuno-oncology therapies. The company's proprietary technology platform leverages a deep understanding of the biology of immune cells and their interactions with cancer cells to develop therapies that can selectively activate or suppress immune responses to cancer. Artiva's lead product candidate, AB-101, is a first-in-class, off-the-shelf, allogeneic cell therapy that targets solid tumors by activating natural killer (NK) cells. The company was founded in 2019 and is headquartered in South San Francisco, California.
Learn more about Artiva Biotherapeutics
Size
20 employees
Industry
Net Income
-$16
Founded
2019
NASDAQ

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