(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