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Senior Manufacturing Specialist, CDMO / CMO
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Full-time
- Are you looking to be part of a game-changing organization that has the potential to help cure cancer?
- NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.
- Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical production including but not limited to the manufacturing of the intermediate and finished dose production processes, including pre-production setup, manufacturing processes, post-production activities, and waste stream management.
- Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Work Instructions (WI), and Production Checklists while upholding NorthStar's QMS guidelines.
- Three (3) years of experience in radiopharmaceuticals, pharmaceuticals, or biologics, with knowledge of cGMP and FDA requirements is required.
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