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
BenefitsWe offer a competitive salary, a comprehensive benefits package and advancement opportunity.
