Director, Analytical Development — Cell Therapy

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

Benefits offered by this job

Comprehensive benefits package

401(k) and ESPP options

Paid time off and parental leave

Job summary

United Therapeutics seeks a Director of Analytical Development to lead a high-performing team and shape analytical strategy for an iPSC-derived cell therapy program. You will guide method development, qualification, and scale-up in GMP environments across the product lifecycle.

Responsibilities include defining testing strategies, mentoring staff, authoring SOPs, and coordinating technology transfer to CDMOs and CTLs, while aligning with Regulatory and Quality groups to support regulatory

Qualifications

• 15+ years in biotech/pharma, preferably cell and gene therapy, with advanced degree.
• 7+ years in managerial roles leading analytical development teams.
• Experience with potency and characterisation assays for cell therapy products.
• Regulatory guidelines and industry standards for analytical method development and transfer.

Responsibilities

• Lead strategy and roadmap for analytical development in iPSC-derived cell therapy.
• Mentor Analytical Development staff and manage resources.
• Oversee SOPs, test methods, and regulatory submissions support.
• Drive technology transfer to CDMOs/CTLs and ensure QA compliance.
• Collaborate with Regulatory, Quality, CDMOs, CTLs and other R&D stakeholders.

Skills

Biotech/biopharma leadership

Analytical method development

Potency assays

Flow cytometry

RT-PCR / ddPCR

Regulatory knowledge (CMC)

Team leadership

Transfer to CDMOs/CTLs

Quality systems (GMP/QC)

Problem solving / troubleshooting

Education

PhD in biological sciences / immunology / cell biology / bioengineering

MS in biological sciences / immunology / cell biology / bioengineering

BS in biological sciences / immunology / cell biology / bioengineering

Tools

Cell therapy analytical methods

qPCR / ddPCR platforms

CDMOs/CTLs coordination

Job description

United Therapeutics seeks a Director of Analytical Development to lead a high-performing team and shape analytical strategy for an iPSC-derived cell therapy program. You will guide method development, qualification, and scale-up in GMP environments across the product lifecycle.

Responsibilities include defining testing strategies, mentoring staff, authoring SOPs, and coordinating technology transfer to CDMOs and CTLs, while aligning with Regulatory and Quality groups to support regulatory