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Astellas Pharma QC Analytical Associate II, Cell Therapy 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 QC Analytical Associate II opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Analytical Associate II. This position provides Quality Control qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP background with method validation and quality control testing experience. Essential Job Responsibilities: * Perform routine in-process and release QC testing of AIRM cell products. * Execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and troubleshooting. * Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability, Cell growth and various parenteral assays (Visual Appearance, Content Uniformity, pH, Osmolality). * Maintain, calibrate and operate GMP equipment and instruments supporting QC testing. * Track and test products according to stability protocols. * Culture and maintenance of cell lines and stem cells. * Work with internal and external resources to maintain lab in a GMP state * Monitor and trend QC data. * Support validation and testing of cell bank programs. * Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability. * Perform shipment of materials for QC testing to contract labs and perform data review. * Author, revise and review SOPs, qualification/validation protocols and reports. * Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations and CAPAs related to analytical procedures. * Monitor the GMP systems currently in place to ensure compliance with documented policies. * Perform QC lab duties and technical projects as required. Qualifications: Required * BS degree with 3+ years or MS with 0-2 years of laboratory experience * Relevant GMP experience in the quality control department of a biotech and/or pharmaceutical industry. * Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work. Preferred * Bachelor's Degree / Master's Degree with 3+ years Quality Control experience in biotechnology, biology or related field. * Experience with relevant analytical test methods: including PCR, Flow Cytometry, IFA and cell-based assays * Experience with ICH guidelines and parenteral test methods * Experience with 21CFR Part 11 Compliance * Experience with Validation of Analytical Test Methods * GMP Cell Culture experience and Environmental Monitoring * Experience with JMP software and data tracking/trending analysis #LI-JA1 Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Quality Assurance/Quality Control

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