Senior Scientist, Process Development
United Therapeutics Corporation
September 03, 2026
On-site
Cambridge, MA
Operations
Senior Scientist, Process Development (CMC)
Responsibilities:
- Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness, reproducibility, and product quality
- Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation for clinical and commercial needs
- Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP readiness
- Collaborate cross-functionally with Analytical Development and other teams to define critical process attributes and characterize performance
- Design and conduct studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times
- Author/review technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting regulatory submissions
- Analyze, interpret, and communicate results; provide scientific recommendations
- Evaluate emerging scientific literature/technologies to identify innovation opportunities
- Maintain accurate, compliant experimental records; mentor junior scientists/research associates
- Perform all other duties as assigned
Minimum Requirements:
- BS with 10 years (or MS with 10 years, or PhD with 5 years) in cell/developmental biology, tissue engineering, biomaterials, biomedical engineering, or related field
- 5+ years biotech/pharma industry experience
- Technical expertise in iPS expansion and differentiation
- Technical expertise in downstream processing, formulation, and stability (fresh and cryo)
- Experience with lab instrumentation and data software; standard office software
- Experience supporting FDA/other regulatory submissions via technical reports and CMC documentation
- Ability to mentor; design and perform complex experiments
- Excellent written/verbal communication
Preferred Qualifications:
- PhD or MS in relevant disciplines
- Experience developing biomaterial-based cell delivery systems (e.g., hydrogels, injectable matrices, scaffolds, ECM-inspired materials)
- Expertise in automated cell processing equipment (e.g., PBS bioreactor, Rotea, Biowelder, Metaflex, NC200)
- Experience in tech transfer of cell therapy processes to GMP
Responsibilities:
- Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness, reproducibility, and product quality
- Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation for clinical and commercial needs
- Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP readiness
- Collaborate cross-functionally with Analytical Development and other teams to define critical process attributes and characterize performance
- Design and conduct studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times
- Author/review technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting regulatory submissions
- Analyze, interpret, and communicate results; provide scientific recommendations
- Evaluate emerging scientific literature/technologies to identify innovation opportunities
- Maintain accurate, compliant experimental records; mentor junior scientists/research associates
- Perform all other duties as assigned
Minimum Requirements:
- BS with 10 years (or MS with 10 years, or PhD with 5 years) in cell/developmental biology, tissue engineering, biomaterials, biomedical engineering, or related field
- 5+ years biotech/pharma industry experience
- Technical expertise in iPS expansion and differentiation
- Technical expertise in downstream processing, formulation, and stability (fresh and cryo)
- Experience with lab instrumentation and data software; standard office software
- Experience supporting FDA/other regulatory submissions via technical reports and CMC documentation
- Ability to mentor; design and perform complex experiments
- Excellent written/verbal communication
Preferred Qualifications:
- PhD or MS in relevant disciplines
- Experience developing biomaterial-based cell delivery systems (e.g., hydrogels, injectable matrices, scaffolds, ECM-inspired materials)
- Expertise in automated cell processing equipment (e.g., PBS bioreactor, Rotea, Biowelder, Metaflex, NC200)
- Experience in tech transfer of cell therapy processes to GMP