Senior Scientist, Analytical Sciences

About the position

We are looking for a collaborative and technical Senior Scientist experienced in cell culture, immunological techniques, multi-parametric flow cytometry and cell-based functional assays as part of bioassay development. You will deliver new/optimized analytical methods and evaluate new analytical technologies. You will be responsible to develop cell-based analytical methods aligned with vector and cellular therapy product CQAs to enable process development, product characterization, stability and release testing of novel engineered cell therapy products. The Senior Scientist will work with the Process Development and Quality Control teams. This role is based in Santa Monica, CA and reports directly to the Director, Product Analytical Sciences.

Responsibilities

• Provide strategic, technical, and scientific leadership to a technical analytical method development team, assign tasks, review data, and strengthen regulatory concepts (cGMP).
• Advance and implement cell-based bioassay/potency (e.g. cytotoxicity, proliferation, cytokine production) and immunophenotyping by multi-parametric flow cytometry methods from conception through optimization, qualification, and method transfer to Quality Control and external partners as part of an analytical control strategy and to support Process Development.
• Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Work with Process Development, completing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms, and occasionally perform routine assays for characterization.
• Work with Quality partners during technology transfers, help draft qualification/validation protocols/reports.
• Write, review and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment.
• Participate in group and department meetings, present scientific data, provide expertise in areas of responsibility.
• Maintain, calibrate and operate analytical equipment and instrumentation that is used routinely in execution of assays.

Requirements

• 7+ years with BS/BA; 5+ years with MS/MA; 2+ years with PhD in Immunology, Oncology, Cell Biology, or related discipline.
• Demonstrate knowledge of Process Development of cellular therapy products and Analytical Method Development within a regulated environment.
• First-hand experience in development and qualification of immunoassays, multi-parameter flow cytometry, and cell-based potency methods for release in a QC/regulated environment.
• Demonstrate advanced knowledge in T cell biology and cell signaling pathways.
• Excellent skills in Microsoft Excel, and Powerpoint and data analysis software (e.g. Prism, JMP, FlowJo, CytEpert, SoftMax Pro).
• Ability to think critically and demonstrate troubleshooting and problem solving skills.
• Willing to accept temporary responsibilities outside of initial job description.

Benefits

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.