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Astellas Pharma Senior 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 Senior Scientist, Assay Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The Sr. Scientist is 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, 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 Qualifications: Required * PhD 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 * 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 Preferred * Advanced degree/education * 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 #LI-JA1 Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Research and Development

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