16 часов назад
Senior Scientist, Process Development (iPSC Cell Therapy)
127 500 - 170 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Scientist, Process Development (iPSC Cell Therapy): Developing and optimizing iPSC-derived thymic epithelial progenitor cell manufacturing processes, from expansion and differentiation through downstream processing, formulation, and stability, with an accent on process robustness, reproducibility, and GMP readiness. Focus on designing complex cell therapy studies, developing biomaterial-based delivery and cryopreservation strategies, and preparing CMC documentation for regulatory submissions and clinical manufacturing.
Location: Cambridge, Massachusetts, United States; onsite at the Thymmune location
Salary: $127,500–$170,000 per year
Company
is a public benefit biotechnology and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs. Thymmune, a subsidiary, develops a machine learning-driven iPSC-thymic cell engineering platform for immunodeficiency, transplant-related, and autoimmune diseases.
What you will do
- Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes for improved robustness, reproducibility, and product quality.
- Develop harvest, downstream processing, formulation, fill-finish, fresh, and cryopreservation processes for clinical and commercial manufacturing.
- Lead process characterization studies and prepare technical documentation for technology transfer, process validation, and GMP manufacturing readiness.
- Collaborate with Analytical Development and technical teams to define critical process attributes and advance process understanding.
- Develop biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times.
- Analyze experimental results, provide scientific recommendations, support regulatory submissions, and mentor junior scientists and research associates.
Requirements
- Bachelor’s or master’s degree with 10 years of relevant experience, or PhD with 5 years of relevant experience, in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering, or a related field.
- At least 5 years of biotechnology or pharmaceutical industry experience.
- Technical expertise in iPSC expansion and differentiation process development.
- Experience with downstream processing, formulation, and stability of cell-based products, including fresh and cryopreserved formulations.
- Experience supporting FDA or other regulatory submissions through technical reports and CMC documentation.
- Ability to design complex experiments, communicate scientific results, provide guidance, and mentor junior staff.
Nice to have
- PhD or master’s degree in biology, cell biology, biomedical engineering, tissue engineering, developmental biology, or a related discipline.
- Experience with biomaterial-based cell delivery systems, including hydrogels, injectable matrices, scaffolds, and ECM-inspired or implantable biomaterials.
- Expertise with automated cell processing equipment such as PBS bioreactor, Rotea, Biowelder, Metaflex, and NC200.
- Experience transferring cell therapy processes to GMP manufacturing.
Culture & Benefits
- Mission-driven work focused on unmet medical needs and transplant innovation.
- Medical, dental, vision, and prescription coverage for eligible employees.
- Wellness resources, savings plans including 401(k) and ESPP, paid time off, and paid parental leave.
- Disability benefits and additional company programs.
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