Senior Scientist, Analytical Sciences - Neogene Therapeutics

Position Summary

We are looking for a collaborative and Senior Scientist experienced in cell culture, immunological techniques, multi-parametric flow cytometry and cell-based functional assays to lead bioassay development. You will manage a lab-based team to deliver new/optimized analytical methods and evaluate new analytical technologies. You will develop cell-based analytical methods aligned with vector and cellular therapy product CQAs to promote process development, product characterization, stability and release testing of novel engineered cell therapy products. You will author and review method development reports, test methods and SOPs, protocols, and support the technical review of CMC sections and supporting documents for regulatory filings. 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

• Manage strategic, SME, technical and scientific leadership to a technical analytical method development team.
• 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 operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Work with Process Development, implementing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms.
• Work with Quality partners to draft study protocols, qualification reports, change controls and occasionally perform routine assays as a QC personnel for drug product release and characterization.
• Write, review and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms.
• Provide technical guidance to junior staff, assign tasks, review data, and strengthen regulatory concepts (cGMP)
• 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 in execution of assays.

Education and Experience

• 7+ years with BS/BA; 5+ years with MS/MA; 2+ years with PhD in Immunology, Oncology, Cell Biology, or related discipline
• 1+ years of people management 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
• Hands-on experience in implementing assays and analyzing data using multi-color flow cytometry (10+ colors).
• Excellent skills in Microsoft excel (can maintain complex spreadsheets) and data analysis software (e.g. Prism, JMP, FlowJo, CytEpert, SoftMax Pro)
• Demonstrate knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $105,875 to $132,344. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.