Director, Analytical Development - iPSC Cell Therapy

Scorpion Therapeutics; Cambridge (MA); On-site; USD 185,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced leader to head Analytical Development for iPSC-derived cell therapy products at scale. You will define strategy, drive method development and technology transfer, and oversee GMP/QC documentation and regulatory support.

The role requires extensive biotech experience, strong leadership, and a track record in regulatory filings and cross-functional collaboration with CDMOs, CTLs, and R&D teams.

Qualifications

• 15+ years 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.
• Regulatory/CMC filings experience; strong analytical/problem-solving, communication/technical writing/presentation, urgency/accountability, teamwork, and cross-functional collaboration.

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 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.

Skills

Analytical development

Potency testing

Flow cytometry

RT-PCR

ddPCR

CDMO liaison

Regulatory filings

Cross-functional collab

Education

PhD

MS

BS

Job description

Scorpion Therapeutics is seeking an experienced leader to head Analytical Development for iPSC-derived cell therapy products at scale. You will define strategy, drive method development and technology transfer, and oversee GMP/QC documentation and regulatory support.

The role requires extensive biotech experience, strong leadership, and a track record in regulatory filings and cross-functional collaboration with CDMOs, CTLs, and R&D teams.