• Manage and be a technical expert in the development, scale-up and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing • Support Lilly’s early-phase radiopharmaceutical programs by leading tech. transfer and post-validation development activities of GMP production processes and test methods • Ensure activities are completed within the required budget and timelines • Author and oversee the preparation of CMC regulatory documents required for health authority filings • Work cross-functionally with Regulatory, Quality Assurance, CMC, CDMOs and other vendors • Help to develop and execute overall program strategy for radiopharmaceutical drug product programs • Provide technical support for any post-PV development or qualification activities • 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 associated with radioligands • Monitor and evaluate project budget, tasks and risks; propose mitigation plans when required • Prepare RFPs and lead the evaluation of proposals