Senior Scientist, iPSC Process Development & Scale-Up

United Therapeutics Corporation; Cambridge (MA); In loco; USD 128.000 - 170.000; Tempo pieno

Descrizione del lavoro

United Therapeutics Corporation in Cambridge, MA seeks a Senior Scientist, Process Development to design, optimize, and scale iPSC expansion and differentiation for clinical and commercial manufacturing. You will lead development strategies, collaborate across teams for process understanding, and contribute to regulatory documentation.

The role emphasizes mentorship of junior staff, strong scientific communication, and advancing transformative cell therapies in a fast-paced biotech environment.

Competenze

• Bachelor's degree with 10+ years in cell biology or related field.
• Master's degree with 10+ years in cell biology or related field.
• PhD with 5+ years in cell biology or related field.
• 5+ years of biotech/pharma industry experience.
• Technical expertise in iPS expansion and differentiation process development.
• Experience with regulatory submissions and CMC documentation.

Mansioni

• Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness and quality.
• Design and execute development strategies for harvest, downstream processing, formulation, fill‑finish, and cryo stabilization for clinical and commercial needs.
• Lead process characterization studies and author technical documentation for technology transfer, process validation, and GMP readiness.
• Collaborate with Analytical Development and other teams to define critical process attributes and advance process understanding.
• Design and conduct complex studies to develop biomaterial-based cell delivery approaches and hold times.
• Contribute to FDA and regulatory submissions by authoring and reviewing technical reports, protocols, risk assessments, and CMC documentation.
• Analyze data and communicate results with project teams and leadership to inform decisions.
• Evaluate literature and technologies to identify opportunities for innovation and continuous improvement.
• Maintain accurate records and mentor junior scientists and research associates.

Conoscenze

Cell biology

Developmental biology

Tissue engineering

Biomaterials

Biomedical engineering

Process development

Regulatory submissions

Mentoring

Formazione

Bachelor's degree in a relevant field

Master's degree in a relevant field

PhD in biology/biomedical engineering or related field

Strumenti

PBS bioreactor

Rotea

Biowelder

Metaflex

NC200

Descrizione del lavoro

United Therapeutics Corporation in Cambridge, MA seeks a Senior Scientist, Process Development to design, optimize, and scale iPSC expansion and differentiation for clinical and commercial manufacturing. You will lead development strategies, collaborate across teams for process understanding, and contribute to regulatory documentation.

The role emphasizes mentorship of junior staff, strong scientific communication, and advancing transformative cell therapies in a fast-paced biotech environment.