Scientist I/II, Analytical Development
$125,000–$135,000 year
On-siteSan Diego, California, United States
Job Summary
Conduct experimental design and execution for flow cytometry and cell-based assays to support characterization and release of NK cell therapies. Develop and optimize potency assay methods, perform product characterization, and execute routine laboratory experiments to generate high-quality data. Draft technical reports, standard operating procedures, and test protocols while managing assay transfers to QC teams and external partners. Present findings to cross-functional teams to discuss next steps. Collaborate with R&D, Process Development, and Quality Control departments to advance optimal product development.
Required Qualifications
- Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Microbiology, Cell or Molecular Biology or Biochemistry) with 2+ years or MS with 5+ years of industry experience in analytical development or equivalent demonstrable experience with analytical techniques
- Expertise (equipment and software) with flow cytometry, plate readers, and automated cell counters
- Strong organizational, recording keeping, time management, and communication skills
- Excellent interpersonal, verbal, and written communication skills
- Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams
- Attention to safety, good laboratory practice, and good documentation practice
- Experience in analytical development and testing in a Pharma/Biotech, regulated (GXP) environment
- Experience in cell therapy, immunology, or oncology
Desired Qualifications
- In-depth experience in analytical techniques such as ELISA/MSD and qPCR/ddPCR
- Expertise in cell potency-based assay development
- Experience with NK and or CAR-T cells
- Experience with assay qualification/validation
- Experience with statistical programming or software (e.g., JMP)
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