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Salary: USD 79,000 - 91,000 / annual
Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies.
The Associate II, Quality Control Biology will report to the Associate Director, Quality Control Biology and perform routine cGMP release and stability testing of Artiva's NK cell therapy products, support laboratory investigations, and contribute to continuous improvement of QC systems.
Key responsibilities include:
- Perform routine cGMP release and stability testing, including biological tests, biochemistry, and chemistry-based tests
- Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments
- Write and revise SOPs and test methods supporting cell therapy products
- Support QC equipment IQ/OQ/PQ activities
- Support laboratory investigations and write reports for deviations and Out of Specification results
- Assist in planning GMP release testing, including testing schedules and investigating OOS/OOT results
- Write technical QC protocols and reports
- Support analytical qualification, validation, and method transfer from Analytical Development
- Develop in-depth understanding of NK products, testing, and safety
- Maintain records and databases in accordance with procedures
- Assist with ordering supplies, reagents, and equipment
- Support special QC projects as needed
QUALIFICATIONS:
- Bachelor's degree (BS/BA) in a relevant scientific field, preferably biology or related field
- Minimum 2 years of cGMP QC experience in a cell therapy, biotech, or pharmaceutical setting (required)
- Knowledge and experience supporting cGMP deviations, OOS, and related compliance activities
- Basic knowledge of method transfers, qualifications, and validations; current industry practices; and experience with guidance interpretation and application
- Strong critical thinking and technical writing skills
- Proficiency with Microsoft Word and Excel
