Astellas Pharma Scientist II/Sr. Scientist, Drug Product Development in Marlborough, 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.
This individual will be responsible for process development activities of drug product for clinical phased development programs at AIRM. This position will collaborate closely with various departments including Process Science Technology, 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:
- Takes a leadership role in process and formulation development of cell based drug products.
- Implement scale-up of parenteral drug product processes.
- Manage and implement planning and execution of incorporation appropriate processing materials, and equipment to suit regulatory requirements.
- Direct/conduct studies, summarize the data and prepare study reports.
- Collaborate with mechanical vendors to establish new processes.
- Supervise and/or participate in pilot production and technology transfer to CMO (Contracted Manufacturing Organization).
- Assist in writing CMC regulatory amendments and filings
- Cross functional collaboration with colleagues for process optimization leading to increased manufacturing efficiencies, quality, and yields of drug product.
- Lead the formulation development to ensure timely project delivery.
- Resolve technical and workflow issues in a timely fashion.
- PhD with 3+ years' experience; MS with 7 + years' experience; Bachelors with 8 + years' experience in life sciences with experience in cell handling, aseptic processing, relevant techniques
- Experiences of process development of cell based drug product.
- Experience in development of parenteral drug product such as formulation development and aseptic filling (or auto-filling) process.
- PhD preferred
- 3+ years of industrial experiences of process development of cell product such as scaling up
- 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.
- Experiences of IND, BLA and/or NDA.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development