Posted in Other 8 days ago.
Location: Westborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Astellas is announcing a Sr. Scientist, Process Science and Technology opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
This individual will be responsible for product and process development activities for early-stage development programs at AIRM. This position will collaborate closely with various departments including Research and Development, Assay Development, Regulatory Affairs, cGMP Manufacturing, and QC. The PST Senior Scientist will manage and execute studies required to establish and implement manufacturing processes and to develop processes and materials to improve product quality, performance and yields. He or she will also be expected to proactively contribute to creative solutions for streamlining integrated development plans and to manage risk.
Essential Job Responsibilities:
* Take a leadership role in the design, evaluation, and implementation of prototype and scale-up of production processes.
* Manage and implement planning and execution of incorporation appropriate processing materials, and equipment to suit regulatory requirements.
* Direct and conduct studies, tabulate and analyze results.
* Prepare study reports.
* Draft new and revise existing manufacturing documents for transfer to cGMP
* Technology transfer to cGMP.
* Assist in writing CMC regulatory amendments and filings
* Assist in establishing material specifications and improve manufacturing efficiencies.
* Collaborate with colleagues for optimization of production processes leading to increased efficiencies, quality, and yields.
* Support the manufacturing team to ensure timely project delivery.
* Manage lab inventory for new and existing projects.
* BS with 12+ MS with 8+ or Ph.D. with 5+ years laboratory experience.
* Broad-based knowledge of cell biology.
* Experience in mammalian cell-based processing, products and characterization.
* Exceptional oral and written skills. Expertise in aseptic cell culture processing.
* Experience with embryonic stem cells, iPS cells differentiation protocols.
* Expertise in relevant techniques and related analytical methods: FACS analysis, cell imaging, qRT-PCR ,immunostaining.
* 2+ years of experience in GMP/GLP environment.
* Working knowledge of ocular cells, hematopoietic cells, MSCs.
* Familiarity with exosome vesicle processing and isolation.
* Strong background in immunology and relevant cell-based in vitro assays
* Experience in operating bioreactors and up-stream mammalian scale-up.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled