Associate – Commercial Manufacturing

Eli Lilly and Company • Philadelphia, PA

7d • $65,250 - $145,200

About The Position

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’re looking for people who are determined to make life better for people around the world. Company Overview: Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Overview: The Manufacturing Associate is responsible for ensuring Lilly | Avid Contract Manufacturing Organizations (CMO) are carrying out the agreed upon commercial manufacturing process Lilly sponsored radiopharmaceutical products (Amyvid® and Tauvid®). This role involves archiving manufacturing documentation, monitoring CMO site performance, compiling relevant metrics, preparing detailed reports, and identifying production issues requiring resolution.

Requirements

• Bachelor’s degree in a scientific or technical area

Nice To Haves

• Advanced degree preferred in a scientific or technical area
• Experience working with Radiopharmaceuticals
• Knowledge of cGMP drug substance/drug product manufacturing and quality control
• Ability to work independently in a highly focused manner
• High proficiency in Microsoft 365 environment

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).
• Perform additional responsibilities as assigned.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees