Director - CMC

Isotopia USA
Any Location, IN
Category Engineering
Job Description
Role Overview

The Director, CMC will lead and manage Chemistry and Manufacturing development projects, oversee Quality Control operations, and ensure the safe and efficient production of radiopharmaceutical drug products.

What You Will Do

Responsibilities include leading product and process chemistry development projects, coordinating with third-party equipment vendors, and adhering to all applicable procedures and GMPs.

Why It Might Be a Fit

The ideal candidate will have a strong understanding of GMP requirements, radiation safety practices, and a detail-oriented mindset with excellent organizational and record-keeping skills.

Requirements

  • Minimum of a Bachelor’s degree in Chemistry
  • Previous experience in radiochemistry and radiopharmaceutical product scale-up and optimization
  • Previous experience with compendial USP test methods, ICP-MS / ICP-OES, radio-TLC, and/or direct inoculation sterility testing
  • Strong understanding of GMP requirements and radiation safety practices
  • Detail-oriented mindset with excellent organizational and record-keeping skills

Benefits

  • Competitive salary
  • Comprehensive benefits package
  • Advancement opportunity
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