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At Bristol Myers Squibb we are reimagining the future of cell therapy. But working at Bristol Myers Squibb is anything but usual. Bristol Myers Squibb is an equal opportunity employer.
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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump.
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Company: Bristol-Myers Squibb. Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout. MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process.
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The Quality Engineering and Validation (QEV) team at BMS is responsible for providing Quality Assurance oversight of regulated equipment, facility, utility, site automation (MES, DeltaV, InfoBatch, PI System, etc.
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RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes.
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Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Maintain and Provide Oversight of Quality Assurance Systems including: Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; and GxP Training.
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Key ResponsibilitiesStrategy and Execution Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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The Quality Assurance Specialist will help support operations through quality oversight in a new Radiopharmaceutical facility in Indianapolis, IN. The Quality Assurance Specialist will be responsible for providing oversight over shop floor activities which includes validation and manufacturing operations.
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This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
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This position will report to the Head of GMP Quality and oversee GMP quality systems at RayzeBio Indianapolis. Minimum 5-7 years in GxP (GMP, GLP, GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility.
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Forward to localhost with Webhook.
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Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, regulatory, etc., and demonstrated ability to successfully and effectively cooperate, collaborate and work across functions.
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Cell Therapy functions (CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.) Demonstrated leadership & collaboration working in, or closely with, Supply Chain, GMP Manufacturing Operations, Manufacturing Science & Technology, Project & Program management, Quality Assurance / Quality Control Operations and related functions.
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