Advisor - Translational Radiochemistry

Eli Lilly and Company

5d•$108,000 - $181,500•Remote

About The Position

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. Overview: 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. Position Summary: 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.

Requirements

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.
Proven ability to work independently with strong organization and communication skills.
Demonstrate ability to successfully prioritize projects and manage timelines in a fast-paced environment.
Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines
Position will require up to 50% travel within North America and abroad into the EU.
A valid passport and eligibility to travel into these countries are required.

Nice To Haves

Knowledge of environmental health and radioprotection requirements are considered assets.

Responsibilities

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.

Benefits

This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program.
Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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