Director, Analytical Development

Responsibilities:

• Lead analytical development strategy, priorities, roadmap; develop phase-appropriate, risk-based analytical assays and potency testing for iPSC-derived cell therapy products.
• Recruit/manage/train/mentor Analytical Development staff.
• Lead analytical development and method transfer to support iPSC expansion/differentiation in GMP manufacturing across the product lifecycle.
• Oversee development/authoring/review/approval of SOPs, test methods, and qualification documentation supporting GMP and QC.
• Act as SME for analytical development; lead technology transfer (in-process, release, product characterization) to CDMOs and CTLs.
• Resolve complex QC testing issues during clinical production at CDMOs (person-in-plant support as needed).
• Develop/review/approve analytical development source documents; provide CMC oversight for regulatory submissions; support regulatory responses and influence analytical strategy.
• Lead CTL due diligence, evaluation, and selection; support CDMO selection due diligence.
• Drive continuous improvement; support budget/resource/capital planning.
• Partner cross-functionally (Regulatory, Quality, CDMOs, CTLs, R&D) and perform other assigned duties.

Minimum requirements:

• 15+ years (BS) OR 13+ years (MS) OR 10+ years (PhD) biotech/pharma experience in cell/gene therapy; 7+ years managerial experience.
• Expertise in cell therapy analytical methods (potency assays, flow cytometry-based assays, product characterization); method development/optimization/qualification/transfer.
• Hands-on characterization (flow cytometry, RT-PCR, ddPCR); safety assays for lot release (endotoxin, mycoplasma, sterility, rapid release).
• Analytical control strategies/specifications; stability studies per ICH and shelf-life setting.
• Potency assay development/strategy for cell therapy; experience with CDMOs/CTLs.
• Regulatory/CMC filings experience; strong analytical/problem-solving, communication/technical writing/presentation, urgency/accountability, teamwork, and cross-functional collaboration.

Preferred qualifications:

• PhD/MS in relevant fields; iPSC-derived analytical method development/qualification experience.
• Whole genome sequencing, bioinformatics pipeline, scRNA-seq experience.

Compensation/benefits:

• Salary range: $185,000-$240,000.
• Comprehensive benefits (medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off & paid parental leave, disability, etc.).