Director, CMC: Radiopharmaceuticals & GMP Excellence

Isotopia Molecular Imaging ltd; Westfield (IN); On-site; USD 180,000 - 250,000; Full time

Job summary

Isotopia Molecular Imaging ltd in Indianapolis seeks a Director, CMC to oversee Chemistry, Manufacturing and Controls for radiopharmaceuticals. You will guide development, tech transfer into GMP operations, and ensure data integrity under cGMP.

The role requires leading QC activities, method development, and validation, coordinating with vendors, and maintaining compliance with safety and regulatory standards.

Qualifications

• Bachelor's degree in Chemistry required.
• Advanced degree in Chemistry desired.
• Radiochemistry and radiopharmaceutical scale-up experience required.
• Experience with USP test methods, ICP-MS/ICP-OES, radio-TLC or sterility testing required.
• GMP knowledge required.
• Detail-oriented and able to work in a regulated environment.

Responsibilities

• Lead radiopharmaceutical chemistry development, scale-up, and process optimization.
• Oversee technology transfer of products into GMP manufacturing operations.
• Serve as SME for radiochemistry and radiolabeling.
• Manage QC operations, including method development and transfers.
• Oversee analytical method development and validation for test specifications.
• Execute stability protocols and generate reports.
• Ensure data recording complies with cGMP.

Skills

Radiochemistry

GMP compliance

Quality control

Analytical methods

Regulatory knowledge

Leadership

Education

Bachelor's degree in Chemistry

Advanced degree in Chemistry

Tools

ICP-MS

ICP-OES

Radio-TLC

USP test methods

Job description

Isotopia Molecular Imaging ltd in Indianapolis seeks a Director, CMC to oversee Chemistry, Manufacturing and Controls for radiopharmaceuticals. You will guide development, tech transfer into GMP operations, and ensure data integrity under cGMP.

The role requires leading QC activities, method development, and validation, coordinating with vendors, and maintaining compliance with safety and regulatory standards.