• Scientist II, Manufacturing Science & Technology

    Astellas PharmaMarlborough, MA 01752

    Job #1322401542

  • 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, Manufacturing Science & Technology opportunity at their affiliate Astellas Institute of Regenerative Medicine (AIRM) in Westborough, MA.Purpose:Within AIRM's Manufacturing Science and Technology (MS&T) team, the successful candidate will be responsible for technology transfer, manufacturing technical support, process validation, & training with ability to troubleshoot and solve technical problems. The candidate will work closely within the team and across functional groups to ensure smooth transition of new products and processes from process development into GMP manufacturing. The candidate should be a highly motivated self-starter who is comfortable working in a hands-on environment.Essential Job Responsibilities:* Technical expert in cell culture, including PSC and primary cell culture, PSC differentiation, and cell cryopreservation.* Independently plan and execute experiments, analyze & summarize data.* Perform characterization assays such as Flowcytometry, RT-PCR or ICC/IFA to monitor culture quality and PSC differentiation efficiency.* Optimize procedures as needed, able to effectively troubleshoot technical issues or process deviations to ensure production proceeds as scheduled.* Responsible for development of SOPs, developmental batch records, and technical reports.* Participate in process and technology transfer from Development Groups or other Astellas Sites to AIRM Manufacturing Group.* Support technical training within the team and other groups within GMP operation department.* Assist in overseeing laboratory equipment maintenance and inventory of consumable materials.* Support manufacturing department activities.* Maintain up to date knowledge both scientifically & technically.Qualifications:Required* BS, MS or Ph.D. degree in biology, bioengineering, or related scientific field with relevant laboratory experience of 10+ years for BS, 6+ years for MS, or 3+ years for PhD in a biotechnology, cell therapy or pharmaceutical industry, or stem cell research field.* Extensive cell culture experience with solid knowledge of cell biology principles.* Proficiency utilizing MS Office products and basic statistical software* Detail oriented with good organizational skills and documentation practices.* Able to manage priorities and maintain timelines for multiple projects in a fast-pace setting.* Strong oral, written communication and interpersonal skills* Ability to work effectively independently, as well as part of a team* Willing and capable to learn new knowledge and skillsPreferred* Knowledge and Experience with human pluripotent stem cell culture and lineage differentiation.* Knowledge and Experience in development and/or characterization of biologics and/or cell therapy manufacturing process* Knowledge and direct experience in tech transfer* Able to work flexible hours including weekendsEqual Opportunity Employer Minorities/Women/Protected Veterans/DisabledCategory Manufacturing & Operations