QC Analytical, Scientist I

Company: Astellas
Location: Westborough
Posted on: May 28, 2023

Job Description:

Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc 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.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 Massachusetts. AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Analytical Scientist. This position provides Quality Control Analytical qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP and cell culture background with method validation and quality control testing experience.Essential Job Responsibilities:Perform routine in-process and release QC testing of AIRM cell products.Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.Maintain, calibrate and operate equipment and instruments supporting Immunofluorescence, Flow Cytometry, and PCR assays.Track and test products according to stability protocols.Work with internal and external resources to maintain lab in a audit ready 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, Change Requests and CAPAs related to analytical procedures.Monitor the GMP systems currently in place to ensure compliance with documented policies.Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections. Perform QC lab duties and technical projects as required. PDN-993554c5-f69e-442c-9af8-38b2fd3e05dc

Keywords: Astellas, Worcester , QC Analytical, Scientist I, Other , Westborough, Massachusetts