Manager – Commercial Manufacturing

About This Role

This role manages commercial manufacturing processes for radiopharmaceutical products through Contract Manufacturing Organizations (CMOs). It involves monitoring CMO performance, ensuring compliance with standards, and providing technical support.

Responsibilities

• Monitor CMO site performance and evaluate outcomes against contractual requirements, preparing routine summary reports
• Compile and provide manufacturing data as required to support annual product reviews (APRs), investigations, and presentations
• Compile, analyze, and track production performance metrics, identify trends or issues, and notify relevant teams for further investigation or resolution
• Review completed manufacturing batch documentation to confirm compliance with established standards, facilitate continuous improvement projects, and address potential QA or compliance issues with Lilly | Avid management
• Serve as a subject matter expert for the Radiopharmaceutical Commercial Manufacturing (RCM) team regarding Amyvid® and Tauvid® production, quality control processes, and batch record review
• Collaborate across departments to review out-of-specification (OOS) and deviation reports, ensuring technical accuracy and adherence to quality standards
• Provide technical support to CMOs; including visits to CMO locations in the US to observe production, testing, and release of Lilly | Avid sponsored radiopharmaceutical products and confirm compliance with procedures and PET GMP regulations
• Participate in process improvement and new site start-up projects between Lilly | Avid and CMO
• Assist with technical document updates and change control as necessary
• Maintain an understanding of applicable Federal Regulations (e.g., 21 CFR 212)

Requirements

• Bachelor’s degree in a scientific or technical discipline
• 5+ years of pharmaceutical industry experience
• 3+ years of experience in a pharmaceutical GMP‑regulated manufacturing or quality environment
• Demonstrated experience with cGMP regulations, GDP, and data integrity principles
• Experience working within pharmaceutical quality systems, including deviations, CAPA, and change control
• Authorized to work in the United States on a full-time basis

Qualifications

• Bachelor’s degree in a scientific or technical discipline
• Minimum of 5 years of pharmaceutical industry experience, including at least 3 years in a pharmaceutical GMP‑regulated manufacturing or quality environment

Nice to Have

• Advanced degree in a scientific or technical area
• Experience in Radiopharmaceutical drug substance and/or drug product manufacturing
• Ability to work independently in a highly focused manner
• High proficiency in Microsoft 365 environment

Skills

* Required skills

Benefits