Director, Quality Control (QC)

Why Artiva: 

Artiva is a clinical stage biotech company headquartered in San Diego, and has quickly become a leader in the field of natural killer (NK) cell therapy.  We have the potential to treat both hematological and solid tumors using NK cell therapies that address the limitations of CAR-T cell therapies, specifically with regard to safety, scale of production and off-the-shelf access.  Our established manufacturing-first approach has enabled us to produce, store and ship our product candidates and make them accessible like traditional protein biologic therapies, and our platform has been validated by a major collaboration with Merck. Artiva has raised roughly $200 million, and our product development roadmap includes the potential to initiate up to four additional clinical trials over the next 18-24 months.  

Our Mission: 

At Artiva, our mission is to deliver highly effective, off-the-shelf allogeneic cell therapies that are also safe and accessible to cancer patients. 

Job Summary:

Artiva is looking for an exceptional individual to join our growing team as Director, Quality Control. This position will report directly to the Senior Director, Quality, and lead the setting up and maintenance of the QC laboratory.

Key Responsibilities:

• Develop and manage Artiva’s Quality Control (QC) program.
• Establish QC timelines, budgets, and SOPs.
• Lead the effort to setup QC laboratories, including hiring, procuring and on-boarding equipment.
• Develop a release and stability testing program. Establish in-house methods and identify appropriate outsourced contact testing laboratories.
• Develop and implement an Environmental Monitoring program for EMPQ and routine monitoring.
• Provide oversight for investigations related to departmental deviations, out-of-specifications, and EM excursions.
• Support analytical qualification and validation, as necessary (e.g., intermediate precision).
• Oversee the transfer and optimization of analytical methods from Analytical Development or contract laboratories.
• Evaluate test results and propose acceptance criteria and control limits, which are statistically justified.
• Provide technical support, training, and advice on analytical testing issues and investigations as required.
• Perform or oversee special studies, supplemental process qualifications, etc.
• Develop an in depth understanding of NK and CAR-NK products, testing, and safety.
• Operate and troubleshoot (as needed) ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Maintain records and databases in accordance with procedures.

• Develop and manage department performance metrics.

Supervisory Responsibilities:

• Supervise Quality Control personnel as required.

Education and Experience:

• BS/Masters in a scientific field relevant to cell therapy
• 12 years of US regulatory compliance experience in biologics or pharma
• 3 years of cell therapy experience
• 3 years of supervisory experience
• Advanced understanding of current Good Manufacturing Practices as they relate to the testing of cell therapy products for human clinical trials
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application
• Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs
• Excellent verbal and writing skills
  

Artiva Biotherapeutics is an equal employment opportunity employer.