Senior CMC Technical Program Leader – Radiopharma

Perspective Therapeutics

United States

On-site

USD 180,000 - 240,000

Full time

6 days ago
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Job summary

Perspective Therapeutics is seeking a Director, CMC Technical Program Management, reporting to the Vice President, CMC Isotope Manufacturing, to lead cross-functional planning for radiopharmaceutical development, regulatory submissions, technology transfer, and manufacturing readiness.

The role partners with CMC, Production, Regulatory, Quality and Technical Operations to translate complex development and manufacturing challenges into executable plans, accelerate delivery, and strengthen program

Qualifications

  • Advanced degree in pharmaceutical sciences, chemistry, or related life sciences.
  • Strong program and project management experience in pharma with cross-functional teams.
  • 10+ years in pharmaceutical/biotech or radiopharmaceutical roles with complex initiatives.
  • Experience supporting regulatory submissions and CMC documentation.

Responsibilities

  • Serve as senior CMC program leader translating development and regulatory objectives into integrated plans.
  • Develop understanding of Pb-212 manufacturing, analytical methods, process development and tech transfer.
  • Maintain integrated execution plans across CMC, manufacturing, QA, regulatory, and supply chain.
  • Drive strategic and operational planning for CMC from early development to commercialization.
  • Coordinate cross-functional CMC deliverables to support regulatory submissions and readiness.
  • Lead technology transfer planning with CMOs/CDMOs and track milestones and risks.
  • Lead CMC risk management, including mitigation plans and critical path escalation.
  • Support regulatory strategy and submissions (INDs, IMPDs, NDAs/BLAs) with Regulatory Affairs.

Skills

CMC development
Cross-functional leadership
Regulatory strategy
Project planning & tracking
Risk management
Analytical skills

Education

Advanced degree in pharmaceutical sciences / life sciences

Tools

MS Project
Excel
SharePoint
PowerPoint

Job description

Perspective Therapeutics is seeking a Director, CMC Technical Program Management, reporting to the Vice President, CMC Isotope Manufacturing, to lead cross-functional planning for radiopharmaceutical development, regulatory submissions, technology transfer, and manufacturing readiness.

The role partners with CMC, Production, Regulatory, Quality and Technical Operations to translate complex development and manufacturing challenges into executable plans, accelerate delivery, and strengthen program

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