Analytical Development Scientist — Cell-Based Potency(Temp)

TCWGlobal; San Diego (CA); On-site; USD 42,000 - 60,000; Full time

Job summary

TCWGlobal is seeking an Analytical Development Scientist (Temporary) to advance analytical methods for biologics, focusing on cell-based potency assays and MOA-related endpoints. The role entails developing, optimizing, and transferring assays for AAV gene therapies and mAbs.

The candidate will work onsite in San Diego, applying strong lab skills, data interpretation, and collaboration with cross-functional teams to ensure robust, reproducible results across development stages.

Qualifications

• PhD or equivalent with industry experience in analytical development for biologics.
• Experience with cell-based potency assays and analytical method transfer.
• Strong lab skills and ability to work with cross-functional teams.

Responsibilities

• Develop, optimize, and troubleshoot cell-based functional potency assays for AAV gene therapies.
• Design and execute assays to evaluate transgene expression, biological activity, viral transduction, infectivity, and MOA-related endpoints.
• Investigate assay variability and optimize parameters for robustness and reproducibility.
• Analyze data, evaluate assay performance, and apply appropriate statistics.
• Maintain accurate lab records and data integrity across experiments.
• Support method transfers to QC labs and external CDMOs.
• Prepare SOPs, qualification/validation protocols, reports, and transfer docs.
• Collaborate with cross-functional teams to establish reliable analytical methods.
• Contribute to analytical control strategy development and method comparability assessments.

Skills

Mammalian cell culture

Cell-based potency assays

Data analysis

Statistical evaluation

Scientific writing

Cross-functional collaboration

Onsite collaboration

Education

PhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or related field

Masters with at least 3 years relevant industry experience

Bachelor's with at least 5 years relevant industry experience

Tools

qPCR

ddPCR

RT-qPCR

Flow cytometry

MSD assays

LC-MS/MS

Capillary electrophoresis

Western blotting

Job description

TCWGlobal is seeking an Analytical Development Scientist (Temporary) to advance analytical methods for biologics, focusing on cell-based potency assays and MOA-related endpoints. The role entails developing, optimizing, and transferring assays for AAV gene therapies and mAbs.

The candidate will work onsite in San Diego, applying strong lab skills, data interpretation, and collaboration with cross-functional teams to ensure robust, reproducible results across development stages.