Director, Analytical Development
United Therapeutics Corporation
August 31, 2026
On-site
Cambridge, MA
Operations
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.).
- 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.).