Job Description, Responsibilities & Requirements
About the Position
We are currently seeking a motivated and experienced Associate Scientist to join a well-known client’s Analytical Development team in San Diego, CA. This role supports the development, optimization, and transfer of analytical methods for cell therapy products, with a focus on CAR T characterization and release testing.
The Associate Scientist will work closely with cross-functional teams to design and execute cell-based assays, support process development, and ensure robust analytical methods aligned with regulatory requirements. This is an excellent opportunity to contribute to cutting-edge cell therapy programs in a fast-paced and collaborative research environment.
Responsibilities
- Develop and optimize analytical test methods for cell therapy product characterization and GMP release in accordance with ICH, USP, and EP guidelines.
- Support analytical testing, qualification, and validation activities.
- Perform and support cell-based assays, immunoassays, and flow cytometry experiments.
- Conduct product characterization and support process development activities for CAR T cell products.
- Evaluate reagents and laboratory supplies to meet QC and GMP standards.
- Author and co-author SOPs, technical reports, and analytical sampling plans.
- Maintain accurate laboratory documentation with strong attention to detail.
- Support assay transfer to internal and external QC laboratories and provide lifecycle support.
- Summarize, analyze, and present scientific data to project teams.
- Evaluate and implement new technologies to improve assay robustness and reproducibility.
- Set up, monitor, and analyze cell culture processes.
- Collaborate with R&D teams to deepen understanding of analytical methods for critical quality attributes (CQAs).
Requirements
- BS or MS degree with 5+ years of relevant experience in a biotech or pharmaceutical environment.
- Strong experience in human T cell biology and cellular immunology techniques.
- Hands-on experience with cell-based assays, immunoassays, and flow cytometry.
- Experience with aseptic cell culture, including primary human cells and cell lines.
- Demonstrated expertise in bioassay development, optimization, and execution.
- Strong ability to perform data analysis and maintain accurate laboratory records.
Nice to Have
- 2+ years of cell therapy industry experience.
- Experience with T cell functional assays (potency, cytotoxicity, ELISA, proliferation, Luminex).
- Familiarity with molecular techniques such as qPCR, ddPCR, and electrophoresis.
- Experience with design of experiments (DoE) for assay development.
- Prior experience drafting SOPs and technical documents.
We Offer
- Competitive salary range: $0 - $44.83 Per Hour
- Contract employment type
- On-site work location in San Diego, CA
- Comprehensive benefits for full-time employees, including health coverage, life insurance, disability insurance, and 401k benefits.
About the Company
At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Clinical is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Clinical complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].
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