Director, CMC – Radiopharmaceutical Scale-Up & GMP

Isotopia USA; Westfield (IN); On-site; USD 180,000 - 240,000; Full time

Job summary

Isotopia USA is seeking a Director, CMC (Chemistry, Manufacturing and Controls) to lead radiochemical development and scale-up for radiopharmaceutical products. You will oversee QC operations, method development and validation, and ensure cGMP compliance and radiation safety.

The role requires driving tech transfer into GMP manufacturing and coordinating with production and third-party labs. The ideal candidate has a chemistry PhD or equivalent experience with radiochemistry, scale-up,

Qualifications

• Bachelor’s degree in Chemistry is required.
• Advanced degree in chemistry is desired.
• Experience in radiochemistry and radiopharmaceutical scale-up is required.
• Experience with USP test methods, ICP-MS/ICP-OES, radio-TLC and sterility testing is required.
• Strong GMP knowledge and radiation safety practices are required.
• Detail-oriented with excellent organizational and record-keeping skills.

Responsibilities

• Lead and manage radiopharmaceutical development projects, including scale-up and optimization.
• Support tech transfer into GMP manufacturing operations.
• Serve as SME for radiochemistry and radiolabeling of products.
• Oversee QC operations, method development and validation.
• Execute stability protocols and generate reports.
• Ensure compliance with cGMP and radiation safety requirements.

Education

Bachelor’s degree in Chemistry

Advanced degree in Chemistry

Tools

ICP-MS

ICP-OES

Radio-TLC

Direct inoculation sterility testing

Job description

Isotopia USA is seeking a Director, CMC (Chemistry, Manufacturing and Controls) to lead radiochemical development and scale-up for radiopharmaceutical products. You will oversee QC operations, method development and validation, and ensure cGMP compliance and radiation safety.

The role requires driving tech transfer into GMP manufacturing and coordinating with production and third-party labs. The ideal candidate has a chemistry PhD or equivalent experience with radiochemistry, scale-up,