Senior Scientist, Process Development

United Therapeutics Corporation•Cambridge, MA

66d•$127,500 - $170,000•Onsite

About The Position

At Thymmune, you'll join a team pushing the boundaries of cell therapy and transplant innovation through advanced iPSC-derived manufacturing technologies. As a Senior Scientist, Process Development, you'll play a pivotal role in designing and optimizing processes that support the development of transformative therapies, helping move breakthrough science from concept to clinic. It's an opportunity to solve tough scientific challenges, collaborate with world-class colleagues, and contribute to a future where more patients have access to life-changing treatments. The Senior Scientist, Process Development (CMC) will plan, conduct, and support process development activities for an iPSC-derived thymic epithelial progenitor cell process. Activities include scale-up, expansion, differentiation (2D and 3D), harvest, wash, formulation and stability to ensure process reproducibility and robustness.

Requirements

A Bachelors Degree with 10 years of relevant experience in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field OR a Masters degree with 10 years of relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field OR a PHD with 5 years relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field
5+ years of biotech/pharma industry experience
Technical expertise in iPS expansion and differentiation process development
Technical expertise in downstream processing, formulation and stability of cell based products including fresh and cryo formulation development
Experience with laboratory instrumentation and data software; with appropriate word processing, spreadsheet, presentation and related standard software
Experience supporting FDA and/or other regulatory submissions through preparation of technical reports and CMC documentation
Ability to mentor junior scientists and research associates and provide scientific guidance across projects
Ability to design and perform complex and technically challenging experiments
Excellent written, verbal communication and presentation skills

Nice To Haves

Doctor of Philosophy (PhD) or a Master’s Degree in biology, cell biology, biomedical engineering, tissue engineering, developmental biology, or related scientific discipline
Experience developing biomaterial-based cell delivery systems, including hydrogels, injectable matrices, scaffolds, extracellular matrix (ECM)-inspired materials, or other implantable biomaterials
Expertise in automated cell processing equipment such PBS bioreactor, Rotea, Biowelder, Metaflex, NC200, and others
Experience in tech transfer of cell therapy processes to GMP

Responsibilities

Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve process robustness, reproducibility, and product quality
Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation processes to support clinical and commercial manufacturing needs
Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP manufacturing readiness
Collaborate cross-functionally with Analytical Development and other technical teams to define critical process attributes, characterize process performance, and advance process understanding
Design and conduct complex studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times
Contribute substantively to FDA and other regulatory submissions by authoring and reviewing technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting product development and clinical advancement
Analyze, interpret, and communicate experimental results to project teams and leadership, providing scientific recommendations that support program objectives and development decisions
Evaluate emerging scientific literature, technologies, and industry trends to identify opportunities for innovation and continuous improvement within the process development function
Maintain accurate and compliant experimental records and provide scientific guidance, technical expertise, and mentorship to junior scientists and research associates
Perform all other duties as assigned