Astellas Pharma Scientist I, 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 I, Drug Product Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
This individual will be responsible for formulation and process development of drug product for clinical phased development programs at AIRM. This position will collaborate closely with various departments including Process Science Technology, Regulatory Affairs, cGMP Manufacturing, QA and QC. The DPD Scientist will manage and execute studies required to establish manufacturing processes of cell-based 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:
- Take a leadership role in process and formulation development of cell based drug products.
- Implement scale-up of drug product production 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 equipment.
- Assist in writing CMC regulatory document and filings
- Collaborate 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.
- Bachelors with 8 + years; MS with 6 + years or Ph.D 0-3 years of experience in life sciences with experience in cell handling, aseptic processing, relevant techniques
- Deep understanding of cell biology
- Self-reliant and self-motivated to learn process/formulation development of cell drug product
- Capable of meticulous GDP (Good Document Practice) record keeping
- Ability to work independently but proactively with a team
- Excellent communication skills
- D preferred
- Experience in development of parenteral drug product such as formulation development and aseptic filling (or auto-filling) process.
- 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 and down-stream mammalian scale-up experience.
- Experiences of PV (Process Validation) or PPQ (Process Performance Qualification) of drug substance or drug product.
- Experiences of BLA and/or NDA.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Research and Development