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CMC Project Manager
in Healthcare + Life Sciences PermanentJob Detail
Job Description
Sr. Manager/AD CMC- New Jersey (Hybrid 3 days a week onsite)
Job Description
Senior Manager/AD, CMC, Radiopharmaceuticals will manage the CMC aspects of radiopharmaceutical drug candidates, such as Ac225 and In 111. This role demands proficiency in radiopharmaceuticals, radiometal chemistry, and CMC documentation. Key responsibilities include selecting and managing CDMOs, overseeing technology transfer, ensuring regulatory compliance, and maintaining supplier relationships. The candidate will review technical documents, guide raw material selection, and co-write CMC sections for regulatory submissions.
Requirements
- A PharmD or PhD in a relevant field and over five years of experience in radiopharmaceuticals are required.
- Strong technical knowledge, problem-solving skills, and familiarity with FDA and EMA regulations are essential.
- The role also involves staying updated on technological advancements and communicating effectively with stakeholders.
- Fluency in English is necessary.
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