Senior Scientist, Process Development
iviva medicalSomerville (MA)
$127,500.00 - $170,000.00
Apply (opens in a new tab)Senior Scientist, Process Development
Posted 3 days ago
iviva medicalSomerville (MA)
SENIORITY
Lead
SALARY
$127,500.00 - $170,000.00
About the role
Senior Scientist, Process Development (CMC) 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. 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.
Minimum 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.
Preferred Qualifications:
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.The salary range for this position is $127,500.00 - $170,000.00 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. This role is based in our Cambridge, MA Thymmune location. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
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