Advisor - Translational Radiochemistry

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Reporting to the Director, Translational Radiochemistry, the selected candidate will manage and be a technical expert in the development, scale‑up and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing, and the preparation and authorship of CMC‑related documents required to support regulatory filings. This position will be within the Translational Radiochemistry team which is part of the Early Phase CMC group.

• Support Lilly’s early‑phase radiopharmaceutical programs by leading tech transfer and post‑validation development activities of GMP production processes and test methods used in the production of Lilly’s radioligands at internal and external sites.
• Ensure activities are completed within the required budget and timelines.
• Author and oversee the preparation of CMC regulatory documents required for health authority filings including initial filings (i.e. IND, CTA, CTIS), amendments and notifications. Work cross‑functionally with Regulatory, Quality Assurance, CMC, CDMOs and other vendors to ensure completion of the documents within the required timelines.
• Help to develop and execute overall program strategy for the delivery of radiopharmaceutical drug product programs from candidate identification to early‑phase clinical studies.
• Provide technical support for any post‑PV development or qualification activities in relation to GMP manufacturing process and analytical test methods.
• Support routine production operations including on‑site manufacturing support, technical data review, troubleshooting, investigations, and implementation of CAPAs.
• Prepare and coordinate the execution of protocols (i.e. tech. transfer, process validation, method validation) associated with radioligands in accordance with applicable regulatory guidelines and the established Quality Management System.
• Monitor and evaluate project budget, tasks and risks; propose mitigation plans when required to ensure deadlines are met.
• Prepare RFPs and lead the evaluation of proposals to select new vendors and to initiate the addition of new projects with current vendors.
• Act as an engagement owner to select and onboard new radiopharmaceutical CDMO vendors to Lilly systems.
• Play a critical role in developing and maintaining good relationships with partners, CDMOs, vendors and suppliers.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and other quality or regulatory requirements.
• Provide verbal and written reports and presentations in a clear and concise manner.
• Perform other duties as assigned.

• PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline. PhD in radiochemistry or chemistry is preferred.
• Minimum 8 years for PhD or 10 years for MSc of relevant industry experience in radiochemistry, radiopharmaceutical manufacturing, organic chemistry, or process chemistry.
• Experience working in a pharmaceutical GMP manufacturing environment.
• Strong process radiochemistry and analytical chemistry skills. Demonstrated experience with imaging radioisotopes (F-18, Ga-68) and therapeutic radioisotopes (Lu-177, Ac-225) is required.
• Knowledge of environmental health and radio protection requirements…