Manager – Commercial Manufacturing

<p style="text-align:left">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.</p><p style="text-align:inherit"></p><p><b>Company Overview:</b></p><p></p><p>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.</p><p></p><p>The Commercial Manufacturing Manager 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.</p><p>          </p><p><b>Responsibilities: </b></p><ul><li>Monitor CMO site performance and evaluate outcomes against contractual requirements, preparing routine summary reports.</li><li>Compile and provide manufacturing data as required to support annual product reviews (APRs), investigations, and presentations.</li><li>Compile, analyze, and track production performance metrics, identify trends or issues, and notify relevant teams for further investigation or resolution.</li><li>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.</li><li>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.</li><li>Collaborate across departments to review out-of-specification (OOS) and deviation reports, ensuring technical accuracy and adherence to quality standards.</li><li>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.</li><li>Participate in process improvement and new site start-up projects between Lilly | Avid and CMO.</li><li>Assist with technical document updates and change control as necessary.</li><li>Maintain an understanding of applicable Federal Regulations (e.g., 21 CFR 212).</li><li>Perform additional responsibilities as assigned.</li></ul><p></p><p><b>Basic Qualifications:</b></p><ul><li>Bachelor’s degree in a scientific or technical discipline</li><li>Minimum of 5 years of pharmaceutical industry experience</li><li>At least 3 years of experience in a pharmaceutical GMP‑regulated manufacturing or quality environment</li><li>Demonstrated experience with cGMP regulations, GDP, and data integrity principles</li><li>Experience working within pharmaceutical quality systems, including deviations, CAPA, and change control</li></ul><p></p><p><b>Additional Skills/Preferences:</b></p><ul><li>Advanced degree in a scientific or technical area</li><li>Experience in Radiopharmaceutical drug substance and/or drug product manufacturing</li><li>Ability to work independently in a highly focused manner</li><li>High proficiency in Microsoft 365 environment</li></ul><p></p><p><b>Additional Information:</b></p><ul><li>Must be willing and able to travel within the US 10% of the time.</li></ul><p></p><p></p><p style="text-align:left">Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation"><span><span><span class="WCO0">https://careers.lilly.com/us/en/workplace-accommodation</span></span></span></a>) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p style="text-align:inherit"></p><p style="text-align:left">Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p style="text-align:left"><br />Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is</p>$65,250 - $145,200<p style="text-align:inherit"></p><h3></h3><p style="text-align:left">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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p style="text-align:inherit"></p><p style="text-align:left">#WeAreLilly</p>