Astellas Pharma Sr. Scientist, Assay 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 Sr. Scientist, Assay Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
Responsible for high level scientific experimental and assay development design, data analysis and final reports. Provides planning and scientific direction for interdisciplinary projects within the scope of his/her specific expertise.
This person will manage a team and work closely with R&D and CMC and GMP technical operations groups to ensure development and execution of projects according to company goals.
Essential Job Responsibilities:
Lead a team of internal scientists and be responsible for their scientific and career development goals
Scheduling technical staff, as appropriate, for each project
Collaborate with upstream and downstream functions to ensure strong cross functional collaborations and integrated process and product development and characterization
Develop assays and analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies for release/stability criteria for various scenarios including accelerated product development
Ability to pre-qualify assays in accordance with ICH guidelines, provide reports and lead tech transfer of methods to Quality Control for qualification of assays
Support CMC filing activities for various pre-INDs, INDs, IMPDs, and BLAs and track analytical development /QC commitments
BS with 12+, MS with 8+ or Ph.D. with 5+ years laboratory experience
Excellent organizational, written and oral communication skills to convey technical and non-technical information clearly to a diverse audience
Ability to work productively in a collaborative and cross functional team environment within and outside of AIRM
Significant and established experience in the biopharmaceutical industry with relevant experience in product and process characterization for cell/gene-based therapies
Demonstrated experience and knowledge in tech transfer of methods and life cycle management
Theoretical and hands-on knowledge and experience with methods used for molecular characterization of mammalian cells, particularly cell culture techniques, immunoassays and gene expression analysis, with a strong knowledge base of molecular based assays included but not limited to qPCR
Provide leadership in developing assays for various process streams, evaluating matrix effects and material storage
Conduct testing and train analysts at the bench level, analyze data, and review results
Keep current with advances in analytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing process and product understanding
Collaborate with QC to transfer and/or qualify key in-process methods or release methods
Operate under Good Documentation Practice for efficient data management and retrieval
Generate assay development reports
Support investigations and CAPAs as required
Interact closely with multiple interdisciplinary groups (R&D, MFG, QA, QC, IT, Process Science Technology, Drug Product Development, Facilities, etc.)
Proven ability to work with at a high level of integrity, accuracy, and attention to detail
D. in chemistry, biology, biochemistry, molecular biology or related technical discipline with a minimum of 5+ years of biopharmaceutical analytical experience or Masters in a similar discipline with 8+ of the previously mentioned experience
Experience in cell-based therapies and required assay development for each cell type
Working knowledge of HPLC, flow cytometry, cell-based assays, in particular molecular based assays
Background in iPSC and hESC cell line characterization
Strong experience/proficiency in ocular, immunomodulatory, or other disease states.
Experience with due diligence of business development opportunities in early and late stage programs
Category Research and Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans