Advisor – Translational Radiochemistry

Role Overview

• 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.

Requirements

• PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline
• 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)
• Knowledge of environmental health and radioprotection requirements are considered assets
• 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
• A valid passport and eligibility to travel into these countries are required

Benefits

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)