Analytical Development Scientist

Job Description

Job Description

Analytical Development Scientist (Temporary)

Pay Rate: Up to $37.37/hour

Duration: 12-month contract

Hours: Full-Time

Location: San Diego, CA (Onsite)

Summary

We are seeking a hands-on Analytical Development Scientist to support the development of analytical methods for biologics, including adeno-associated virus (AAV)-based gene therapies and monoclonal antibodies (mAbs).

In this role, you will develop, optimize, troubleshoot, and transfer analytical potency assays, with a primary focus on cell-based functional potency methods. You will also support ligand-binding, molecular, and biochemical assays to ensure analytical methods are robust, reproducible, and appropriate for the stage of product development. The ideal candidate has strong laboratory skills, experience with cell-based assay development, and the ability to collaborate with cross-functional teams and external partners.

What You'll Do

• Develop, optimize, and troubleshoot cell-based functional potency assays, particularly for AAV-based gene therapies
• Design and execute assays to evaluate 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 You Bring

• 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 analytical techniques:
• Cell-based potency assays, including transduction, infectivity, or functional protein expression assays
• Molecular assays, including qPCR, ddPCR, or RT-qPCR
• Flow cytometry and cell-based imaging
• Protein characterization techniques, including Western blotting, capillary electrophoresis, and ELISA
• Meso Scale Discovery (MSD) assays
• Strong analytical, problem-solving, and data interpretation skills
• Excellent written and verbal communication skills
• Strong organizational skills and the ability to collaborate effectively with cross-functional teams
• Ability to work onsite in San Diego, CA

Bonus Points If You Have

• 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

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.