Director - CMC

Isotopia is a global biotech company manufacturing drug products and API for radio-pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Director, CMC (Chemistry, Manufacturing and Controls) to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products.

You will be part of a family, a team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

• Lead and manage Chemistry and Manufacturing development projects including scale-up and optimization of radiopharmaceutical drug products
• Support the tech transfer of radiopharmaceutical drug products into GMP manufacturing operations within the Isotopia operations
• Serve as the Subject Matter Expert for radiochemistry and radiolabeling of drug products
• Oversee the Quality Control operations, including staff, method development, method transfers, and routine QC testing
• Oversee, manage, and lead if necessary analytical method development and validations for the various test specifications required for Isotopia products
• Execute stability protocols and generate reports
• Comply with cGMP requirements for recording of data
• Oversee the chemical and physical testing of raw materials, in-process materials and finished products, using established test methods to provide accurate and reliable data to ensure their strength, identity, and purity.
• Train quality control staff to properly execute analytical tests
• Oversee and ensure success of the technology transfer of product chemistry and manufacturing processes, as well as process improvements to these systems
• Lead product and process chemistry development projects
• Coordinate with third party equipment vendors to schedule routine equipment requalification
• Work with radioactive materials using safe protocols
• Coordinate with production personnel to ensure timely testing and release of intermediate materials and final product
• Coordinate sampling plans and shipment of samples to third party labs for any necessary third-party testing
• Complete technical review of routine test documents, method validation protocols / reports, and method development protocols / reports
• Adhere to all applicable procedures, GMPs, company policies and any other quality or regulatory requirements
• Perform any other tasks as assigned

Requirements

• Minimum of a Bachelor’s degree in Chemistry is required
• Advanced degree(s) in chemistry is desired
• Previous experience in radiochemistry and radiopharmaceutical product scale-up and optimization is required
• Previous experience with compendial USP test methods, ICP-MS / ICP-OES, radio-TLC, and/or direct inoculation sterility testing is required
• Previous experience in pharmaceutical / radiopharmaceutical quality control is desired
• Strong understanding of GMP requirements and radiation safety practices is required
• Detail-oriented mindset with excellent organizational and record-keeping skills
• Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy
• Flexibility to work nights / be on call as required and handle time-sensitive processes
• Strong commitment to safety, ethical conduct, and compliance with regulations
• Physical ability to stand for extended periods, lift moderately heavy objects up to 50 pounds, and to handle frequent stooping and crouching, and wear appropriate PPE
• Manual dexterity for manipulating small items