Analytical Development Scientist

TCWGlobal • San Diego, CA

13h • Onsite

About The Position

Seeking a hands-on Analytical Development Scientist to support analytical method development for biologics, including adeno-associated virus (AAV)-based gene therapies and monoclonal antibodies (mAbs). The role focuses primarily on developing, optimizing, troubleshooting, and transferring cell-based functional potency assays. The scientist will also support ligand-binding, molecular, and biochemical assays to ensure methods are robust, reproducible, and appropriate for the stage of product development. This is a 12-month temporary contract, full-time and onsite in San Diego, California, with a pay rate of up to $37.37 per hour.

Requirements

• PhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or a related field; or a Master's degree with at least 3 years of relevant industry experience; or a Bachelor's degree with at least 5 years of relevant industry experience.
• Strong technical expertise in mammalian cell culture, cryopreservation, cell banking, and aseptic techniques.
• Hands-on experience developing, optimizing, and troubleshooting cell-based potency assays.
• Experience with one or more of the following: cell-based potency assays, including transduction, infectivity, or functional protein expression assays; molecular assays such as qPCR, ddPCR, or RT-qPCR; flow cytometry and cell-based imaging; protein characterization techniques such as Western blotting, capillary electrophoresis, and ELISA; or Meso Scale Discovery (MSD) assays.
• Strong analytical, problem-solving, and data interpretation skills.
• Excellent written and verbal communication skills.
• Strong organizational skills and ability to collaborate effectively with cross-functional teams.
• Ability to work onsite in San Diego, California.

Nice To Haves

• Experience developing AAV gene therapy potency assays, particularly mechanism-of-action-based functional assays.
• Understanding of AAV biology, viral transduction mechanisms, and transgene expression.
• Experience developing potency assays for monoclonal antibodies or other biologics.
• Familiarity with LC-MS/MS or chromatographic separation techniques.
• Knowledge of analytical method qualification, validation, and lifecycle management in accordance with ICH Q2(R2).
• Experience transferring analytical methods to QC laboratories or external CDMOs.

Responsibilities

• Develop, optimize, and troubleshoot cell-based functional potency assays, particularly for AAV-based gene therapies.
• Design and execute assays evaluating transgene expression, biological activity, viral transduction, infectivity, and mechanism-of-action-related endpoints.
• Investigate assay variability and optimize experimental parameters to improve robustness, accuracy, and reproducibility.
• Analyze and interpret experimental data, assess assay performance, and apply appropriate statistical evaluations.
• Maintain accurate laboratory records and ensure data integrity throughout experimental activities.
• Support analytical method and knowledge transfers to internal quality control (QC) laboratories and external contract development and manufacturing organizations (CDMOs).
• Prepare and review analytical procedures, standard operating procedures (SOPs), qualification and validation protocols, technical reports, and method transfer documentation.
• Support analytical method comparability assessments, troubleshoot technical issues, and contribute to analytical control strategy development.
• Collaborate with cross-functional teams to establish reliable, reproducible, and phase-appropriate analytical methods.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level