What are the responsibilities and job description for the SD_Associate Scientist position at Advanced Clinical?
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).
EXPERIENCE
• 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.
Preferred:
• 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.
EDUCATION
• Bachelor’s or Master’s degree in a relevant scientific discipline (e.g., biology, immunology, biomedical sciences) required.
• Equivalent combination of education and experience may be considered.
TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
• Strong technical expertise in cell biology, immunology, and analytical method development.
• Exceptional attention to detail and commitment to high-quality documentation.
• Strong analytical and data interpretation skills.
• Excellent communication and presentation abilities.
• Ability to work independently while collaborating effectively across teams.
• Strong organizational skills with the ability to manage changing priorities.
• Adaptability and enthusiasm for working in a fast-paced, evolving environment.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group 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 Group 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 accommodationrequest@advancedgroup.com.
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