Freelance interpreter for Hanna Interpreting Services connecting bilingual individuals as independent contractors. Manage your own schedule and assist with language access for those in need.
About the role
- Managing CMC regulatory documents and leading GMP production processes for radiopharmaceuticals at Lilly. Supporting cross-functional teams in delivering high-quality drug products for clinical studies.
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.
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)
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