Senior Scientist, Analytical Sciences

Responsibilities

• Provide strategic, technical, and scientific leadership to a highly technical analytical method development team, assign duties, review data, and reinforce 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/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.

Qualifications

• 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.