Associate, Quality Control Bio (Temporary)

About Artiva:

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

Job Summary:

Artiva Biotherapeutics is seeking a skilled and motivated Quality Control Associate who will be reporting to the Senior Manager of Quality Control. The individual will perform routine cGMP release and stability testing of Artiva’s products. Please note that this is a temporary role.

Duties/Responsibilities:

• Assist in ordering supplies and equipment.
• Revise SOPs/Test methods that support Artiva’s cell therapy products as needed.
• Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Support activities for QC equipment IQ/OQ/PQs.
• Perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
• Support the evaluation of QC systems and/or implement system improvements with supervision.
• Support laboratory investigations and reports for deviations and Out of Specification results.
• Document lab work in a thorough and accurate manner.
• Perform all work according to company policies, SOPs, and cGMP practices.
• Assist in technical QC protocols and reports as needed.
• Assist in analytical qualification and validation, as necessary.
• Support the transfer and optimization of analytical methods from Analytical Development (or contract laboratories).
• Develop an in-depth understanding of NK products, testing, and safety.
• Maintain records and databases in accordance with procedures.
• Support other special QC projects as needed.

Qualifications:

• BS or BA or relevant scientific field, preferably in biology or related field.
• At least 1-3 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.

• Knowledge and experience in supporting cGMP deviations, OOS, etc.
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and some experience with guidance interpretation and application

• Adept at learning critical thinking and technical writing skills.
• Computer skills required to operate Microsoft Word and Excel programs.

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $70,000 - $83,000 . Exact compensation may vary based on skills and experience.