Scientist, Molecular Biology
Role Overview
Scientist role on the Analytical Development team supporting molecular analytical methods for cell therapy programs.
The role covers development, optimization, qualification, and validation from early development through commercial launch.
The position is on-site in San Diego, California, and reports to the Director of Analytical Development.
Key Skills for This Role
Full Job Posting
Role Overview
Scientist role on the Analytical Development team supporting molecular analytical methods for cell therapy programs.
The role covers development, optimization, qualification, and validation from early development through commercial launch.
The position is on-site in San Diego, California, and reports to the Director of Analytical Development.
Responsibilities
- Lead design, development, qualification, and validation of molecular biology assays including ddPCR and qPCR.
- Execute laboratory activities including instrument setup, sample preparation, assay execution, troubleshooting, and data analysis.
- Manage cell lines and banks, establish standardized work templates, and perform assay robustness studies.
- Generate, interpret, and present scientific data while maintaining detailed electronic laboratory records.
- Use JMP, GraphPad Prism, or similar tools for statistical analysis and experimental design.
- Prepare technical reports, protocols, standard operating procedures, and other controlled documentation.
- Conduct risk and gap assessments and ensure assays meet phase-appropriate regulatory expectations.
- Collaborate with internal teams, CROs, and vendors on analytical readiness, method transfers, GMP qualification, validation, release, and lifecycle management.
Required Qualifications
- Ph.D. in Immunology, Cell Biology, Neuroscience, or a related field with 2–3 years of relevant industry experience, or an M.S. with 6 or more years of relevant analytical development experience.
- Deep expertise in molecular biology assay development, analysis, and data interpretation.
- Hands-on mammalian cell culture experience involving suspension and adherent cultures in biological safety cabinet operations.
- Strong understanding of ICH guidelines and phase-appropriate analytical method lifecycle management.
- Experience operating and maintaining advanced PCR, spectroscopic, and molecular instruments and their associated software.
- Familiarity with JMP, GraphPad Prism, or equivalent statistical tools.
- Strong technical writing, organization, communication, and collaboration skills.
- Understanding of cell therapy product development and characterization.
Preferred Qualifications
- Experience supporting clinical programs from early phase through commercialization.
- Experience with mammalian cell culture, flow cytometry assays, and cell-based assays.
- Experience transferring assays between CDMOs, CROs, and internal teams.
- Prior experience in a startup or early-phase biotech environment.
Compensation
- The stated salary range is USD 110,000–135,000 annually.
- Actual salary may vary based on experience and company compensation practices.
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