Principal Scientist, Translational Radiochemistry Full-time

Job Opportunity At Lilly

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

Position Summary

Reporting to the Advisor, Translational Radiochemistry, the selected candidate will provide technical expertise and assist in management of the development, scale-up and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing, and the authorship and preparation 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.

Responsibilities

• Support Lilly's early-phase radiopharmaceutical programs by enabling 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 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.
• Review experimental data both internally and from external vendors/partners. Summarize and interpret results and provide direction for future experimental work.
• Partner with quality to provide technical review of manufacturing data, including analysis and trending.
• 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 review protocols (i.e. tech transfer, process validation, method validation) associated with radioligands in accordance with applicable regulatory guidelines and the established Quality Management System.
• Support the preparation of RFPs and evaluate proposals to select new vendors and to initiate the addition of new projects with current vendors.
• Create technology transfer packages for CDMOs by working closely with the pre-clinical / discovery / translational teams.
• Play a key 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.

Basic Requirements

• PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline. PhD in radiochemistry or chemistry is preferred.
• Minimum 2 years of relevant industrial experience in radiochemistry, radiopharmaceutical manufacturing, or process chemistry.
• Experience working on GMP-compliant manufacturing is required. Priority is given to candidates with experience with radiopharmaceuticals and radiometals.
• Experience working with external partners and CDMOs is required.
• Robust knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines is required.
• Possession of a strong technical understanding of manufacturing, radiopharmaceuticals and management software (e.g., Smartsheet, Workday, Veeva RIM).
• Strong fundamental collaboration skills with experience working in a successful matrix managed environment.
• Position will require up to 40% travel within North America and abroad into the EU. A valid passport and eligibility to travel into these countries are required.

Additional Information

The physical demands of this job are consistent with an office environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.