Scientist, Potency Assay Development

Job Description

Scientist, Potency Assay Development

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W2 Contract 12 Months

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San Diego, CA 92130

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$37/hr + Benefits

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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.

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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.

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Key Responsibilities

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

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• 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.
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• Hands-on experience developing, optimizing, and troubleshooting cell-based potency assays.
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• Strong mammalian cell culture experience, including aseptic techniques, cryopreservation, and cell banking.
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• Experience with one or more of the following:
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• Cell-based functional potency, transduction/infectivity, or protein expression assays.
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• qPCR, ddPCR, or RT-qPCR.
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• Flow cytometry or cell-based imaging.
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• ELISA, Western blotting, capillary electrophoresis, or MSD assays.
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• Strong analytical, problem-solving, communication, and collaboration skills.
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Preferred Qualifications

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