Director, Chemistry, Manufacturing and Controls (CMC)

Job overview

The Director, Chemistry, Manufacturing and Controls (CMC) role is onsite in Westfield, IN. Compensation is not specified; the posting describes it as competitive. Isotopia manufactures drug products and active pharmaceutical ingredients for radiopharmaceutical cancer drugs and describes its US headquarters as being in Indianapolis. The director leads radiopharmaceutical product and process development, scale-up, and technology transfer into good manufacturing practice operations. The role also oversees quality control, analytical methods, stability work, testing, and staff training to support safe, compliant, and efficient production.

What you'll do

• Lead chemistry and manufacturing development, scale-up, optimization, and technology transfer for radiopharmaceutical products
• serve as a radiochemistry and radiolabeling subject matter expert
• oversee quality control staff, testing, method development and validation, stability protocols, and technical reviews
• coordinate testing and product release with production personnel
• follow GMP, quality, regulatory, and radiation-safety requirements.

What we're looking for

Skills & competencies

director

cmc

radiopharmaceuticals

chemistry

manufacturing

quality control

gmp

westfield in

isotopia usa

radiochemistry

on-call requirement

Work arrangement

• Weekend coverage required

Benefits & perks

• Competitive salary, comprehensive benefits package, and advancement opportunity.

Why this role

Requires a bachelor's degree in chemistry and experience in radiochemistry and radiopharmaceutical product scale-up and optimization; advanced chemistry degree desired. Flexibility to work nights and be on call as required.

About the employer

Isotopia USA is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.