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Sr. Director - CMC Development
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Full-time
- The individual will provide expertise and leadership in the development and manufacturing of new radiopharmaceutical products working in a fast-paced, multi-disciplinary environment.
- Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless execution of CMC strategies and activities.
- Lead and direct the establishment and operation of Avid’s just-in-time manufacturing of PET radiopharmaceutical investigational medicinal product (IMP) at contract manufacturing organizations (CMO) globally to ensure reliable and sufficient supply to Avid/Lilly clinical trials.
- Ensure compliance with global GMP guidance and regulatory requirements, defined by FDA, EMA, PMDA, and other global health authorities, for CMC activities.
- Drive continuous improvement initiatives to optimize processes, reduce costs, and improve efficiency in PET radiopharmaceutical development and manufacturing.
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