Scientist, Potency Assay Development

Scientist, Potency Assay Development

W2 Contract 12 Months

San Diego, CA 92130

$37/hr + Benefits

We are seeking a hands-on Analytical Development Scientist to support biologics programs, including AAV-based gene therapies and monoclonal antibodies (mAbs). This role focuses on developing, optimizing, and troubleshooting cell-based functional potency assays, along with molecular and biochemical methods.

The ideal candidate has strong laboratory experience, enjoys solving technical challenges, and can collaborate with cross-functional teams to develop reliable analytical methods that support therapeutic development.

Key Responsibilities

• Develop, optimize, and troubleshoot cell-based potency assays, particularly for AAV-based gene therapies.
• Design experiments measuring viral transduction, transgene expression, biological activity, and mechanism-of-action (MOA) endpoints.
• Investigate assay variability and improve accuracy, robustness, and reproducibility.
• Perform analytical testing, interpret data, and maintain accurate experimental records.
• Collaborate with internal QC teams and external CDMOs on method development, qualification, validation, and transfer.
• Prepare SOPs, technical reports, analytical procedures, and method transfer documentation.
• Support assay comparability assessments and analytical control strategies.

Required Qualifications

• PhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or related field; OR MS with 3+ years; OR BS with 5+ years of relevant industry experience.
• Hands-on experience developing, optimizing, and troubleshooting cell-based potency assays.
• Strong mammalian cell culture experience, including aseptic techniques, cryopreservation, and cell banking.
• Experience with one or more of the following:
• Cell-based functional potency, transduction/infectivity, or protein expression assays.
• qPCR, ddPCR, or RT-qPCR.
• Flow cytometry or cell-based imaging.
• ELISA, Western blotting, capillary electrophoresis, or MSD assays.
• Strong analytical, problem-solving, communication, and collaboration skills.

Preferred Qualifications

• AAV gene therapy potency assay development, including MOA-based functional assays.
• Knowledge of AAV biology, transduction mechanisms, and transgene expression.
• Experience with monoclonal antibody or other biologics potency assays.
• Familiarity with analytical method qualification/validation, ICH Q2(R2), and method transfer to QC labs or CDMOs.
• Knowledge of LC-MS/MS or chromatographic techniques.