Senior Scientist, Analytical Sciences

AstraZeneca•Santa Monica, CA

5d•$112,000 - $168,000•Onsite

About The Position

We are seeking 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. The individual will deliver new/optimized analytical methods and evaluate new analytical technologies. The candidate 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 extensively with the Process Development and Quality Control teams. This role is based out of Santa Monica, CA and reports directly to the Director, Product Analytical Sciences.

Requirements

BS/BA in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related discipline with 5+ years of relevant hands‑on experience or MS/MA with 3+ years of relevant experience or Ph.D. with no prior industry experience
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, Word 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.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Experience and aptitude in working in a fast-paced laboratory environment with moderate direction and supervision.

Nice To Haves

Extensive hands-on experience in executing assays and analyzing data using multi-color flow cytometry (10+ colors).
Demonstrate knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.

Responsibilities

Provide strategic, technical, and scientific leadership to a highly technical analytical method development team, assign duties, review data, and reinforce regulatory concepts (cGMP).
Responsible to 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/or external partners as part of an analytical control strategy and in support of 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, executing 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 cross-functionally with Quality partners during technology transfers, assist in drafting 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.