(Senior) Manager, CMC Radiopharmaceuticals
(Senior) Manager, CMC
Remote
Are you passionate about advancing radiopharmaceutical therapies? We're looking for a strategic and technically skilled leader to drive CMC efforts for our pipeline of radiometal-based drug candidates. This is a remote position and candidates based on the East Coast are highly preferred.
What You'll Do:
- Lead end-to-end CMC strategy and execution for radiopharmaceutical programs, from process development to regulatory documentation.
- Manage external manufacturing partners (CDMOs), ensuring smooth tech transfer and compliance with global quality standards.
- Oversee the selection and qualification of raw materials, packaging, and shipping components aligned with regulatory expectations.
- Collaborate cross-functionally and contribute to regulatory filings (INDs, IMPDs).
- Stay ahead of industry trends in alpha radioligand therapy and provide strategic insights to leadership.
What We're Looking For:
- PharmD or PhD in Radiochemistry, Chemical Engineering, or a related life sciences field.
- 6+ years of experience in radiopharmaceutical development, with a strong focus on manufacturing and analytical processes.
- Deep understanding of FDA/EMA regulatory frameworks and CMC documentation.
- Strong communication skills and a collaborative mindset.
Benefits
- Competitive salary with performance-based bonuses
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Generous PTO and paid holidays
- Remote work environment. Candidates on East Coast time zone are preferred
- Professional development support and training opportunities
- A mission-driven team focused on innovation and impact in healthcare
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