Senior Scientist, iPSC Process Development

Unither Pharmaceuticals; Cambridge (MA); On-site; USD 128,000 - 170,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k) plan and ESPP

Paid time off

Job summary

United Therapeutics, Cambridge, MA, seeks a Senior Scientist, Process Development (CMC) to design and optimize iPSC-derived thymic epithelial progenitor cell processes. You will lead expansion, differentiation, scale-up, and downstream steps to ensure robust, high-quality cell therapies for clinical and commercial use.

You will collaborate across teams to define critical attributes, contribute to regulatory documentation, and mentor junior scientists while advancing scalable manufacturing.

Qualifications

• BS/BA with 10+ years in cell biology or related field, or MS with 10+ years, or PhD with 5+ years.
• 5+ years of biotech/pharma industry experience.
• Experience in iPS expansion and differentiation process development.
• Experience in downstream processing, formulation and stability of cell-based products.
• Experience supporting FDA/CMC submissions through technical reports.
• Ability to mentor junior scientists and lead complex experiments.
• Excellent written, verbal, and presentation skills.

Responsibilities

• Lead iPSC expansion, differentiation, and scale-up to improve process robustness and product quality.
• Develop harvest, downstream processing, formulation, fill-finish, and cryopreservation for clinical and commercial needs.
• Lead process characterization and support technology transfer and GMP readiness.
• Collaborate with Analytical Development to define critical process attributes and performance.
• Design studies to optimize delivery formulations and clinical hold times.
• Contribute to regulatory submissions with technical reports and CMC documents.
• Communicate results to teams and leadership and guide project decisions.
• Explore literature and industry trends to drive continuous improvement.
• Mentor junior staff and maintain compliant records.

Skills

iPSC expansion

differentiation

downstream processing

formulation & stability

FDA/CMC documentation

team mentorship

experimental design

data interpretation

regulatory submissions

communication skills

Education

PhD in biology/biomedical engineering

MS in biology/biomedical engineering

Related field Doctoral level (PhD)

Tools

PBS bioreactor

Rotea system

Biowelder

Metaflex

Job description

United Therapeutics, Cambridge, MA, seeks a Senior Scientist, Process Development (CMC) to design and optimize iPSC-derived thymic epithelial progenitor cell processes. You will lead expansion, differentiation, scale-up, and downstream steps to ensure robust, high-quality cell therapies for clinical and commercial use.

You will collaborate across teams to define critical attributes, contribute to regulatory documentation, and mentor junior scientists while advancing scalable manufacturing.