Astellas Pharma Scientist II/Sr. Scientist, Drug Product Development in 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 Scientist II/Sr. Scientist, Drug Product Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
This Scientist will be responsible for process development activities of drug product for clinical phased development programs at AIRM. This position will lead technology/know-how transfer of the programs to GMP team. This position will collaborate closely with various departments including Process Science Technology (Drug substance team), Analytical Development, Regulatory Affairs, cGMP Manufacturing, Quality Control and Quality Assurance. The DPD Scientist will manage and execute studies required to establish manufacturing processes of drug product including scale up aiming for commercialization. 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:
Lead formulation development of cell drug products, and process development including GMP readiness and scale-up toward commercialization.
Manage and implement planning and execution of studies with incorporating appropriate materials and equipment to suit regulatory requirements.
Direct/conduct studies, summarize the data and prepare study reports.
Supervise and/or lead in pilot production and technology transfer to CMO (Contracted Manufacturing Organization) or internal GMP team.
Technical lead in writing CMC regulatory document and filings
Cross functional collaboration with colleagues for process optimization leading to increased manufacturing efficiencies (ex. automations), quality, and yields of drug product with collaborating with mechanical vendors.
Cross functional collaboration with colleagues for regulatory activities such as IND/IMPD/CTA and interaction with health authorities (FDA, EMA, PMDA etc).
Lead the formulation development to ensure timely project delivery.
Resolve technical and workflow issues in a timely fashion.
Scientist II: Bachelors with 10 + years; MS with 7 + years, or Ph.D with 3+ years of experience in life sciences with experience in cell handling, aseptic processing, relevant techniques
Sr. Scientist: Bachelors with 12 + years; MS with 8 + years, or Ph.D with 5+ years of experience in life sciences with experience in cell handling, aseptic processing, relevant techniques
Industrial experiences with 3+ years including regulatory interactions (IND/IMPD/BLA) of biologics (antibody, virus and/or cell)
Experience in development of parenteral drug product, i.e. formulation development and aseptic filling (or auto-filling) process.
Excellent communication skills
Capable of meticulous GDP (Good Document Practice) record keeping
Ability to work independently as well as part of a team
Self-reliant, self-motivated, highly organized
2+ years of experience in GMP/GLP environment.
Working knowledge of ocular cells, bioreactors and down-stream mammalian scale-up experience.
Experiences of PV (Process Validation) or PPQ (Process Performance Qualification) of drug product.
Category Research and Development
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