Astellas Pharma Sr. Scientist, Product Development, Process Science & Technology 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.
Astellas is announcing a Sr. Scientist, Product Development, Process Science & Technology opportunity in Marlborough, MA.
Purpose & Scope:
Demonstrated potential for creativity and excellence. Candidate will design and implement novel cell biology and molecular laboratory research and development projects. Activities will focus on optimizing manufacturing processes for cell based products detined for various clinical applications. This individual will play a key role in developing, scaling up, and codifying processes for existing and new cell-based products suitable for cGMP manufacture.
Essential Job Responsibilities:
- Performs research and/or development in collaboration with others.
- Makes detailed observations, analyzes data, interprets results and write reports.
- Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project goals.
- Prepares technical reports, summaries, protocols, batch records, and quantitative analyses. Investigates, creates and develops new methods and technologies for project advancement.
- Maintains high level of professional expertise through familiarity with scientific literature and novel technologies.
- Uses scientific and practical concepts in accordance with company objectives to solve complex problems in creative and effective ways.
This position interacts with all levels of management on a routine basis and influences strategy. Works on complex and diverse problems giving guidance and suggestions. Actions may have implications on operations, budget and/or credibility. This individual will interface with research, QC, process development, and manufacturing to coordinate a smooth technology transfer of processing from inititial product conception to transfer of product processing to cGMP manufacture for initial clinical trials. This position will also entail preparing documents related to CMC aspects for regulatory submissions.
Reports to the Sr. Director of Process Science and Technology
- PhD scientist with 2-5 years of relevant commercial or academic experience in stem cell biology and/or cell-based products for regenerative medicine.
- Experience with mesenchymal stem cell characterization, processing and/or scale-up.
- Demonstrated industrial or academic achievement, as evidenced by publications in high impact journals or product development portfolio.
- Ability to collaborate with internal and external partners across multiple scientific disciplines.
- Excellent written and oral communication skills are essential.
- Understanding of the cGMP requirements and the CMC regulatory landscape for cell-based clinical therapies.
- Familiarity with in vivo and in vitro quality attribute assessments of MSCs.
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