Associate Director, Manufacturing Package Design

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. We are currently seeking an Associate Director, Manufacturing Package Design. This individual will lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will provide technical and strategic leadership for packaging systems, ensuring solutions meet quality, regulatory, and commercial manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, as well as external Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to drive packaging design, qualification, and launch readiness for late-stage development programs. Responsibilities: Lead the design, development, and technical strategy for primary and secondary packaging components/ systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters , and blister wallet configurations where applicable) supporting late-stage clinical and commercial manufacturing programs. Serve as the manufacturing/CMC packaging design lead representing the company on project teams with external CMOs/CPOs; manage packaging-related technical relationships, including periodic site visits as required . Partner with CMC and Clinical Supply Chain to ensure proper clinical trial packaging and labeling are aligned with production forecasts and product demand Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations and compatibility studies. Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing, including line trials, engineering runs, and scale-up activities. Develop and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements. Partner with Regulatory Affairs to author and review CMC packaging sections of regulatory submissions and respond to health authority queries related to packaging. Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure packaging design supports launch readiness, commercial supply continuity, and product lifecycle management. Identify , lead, and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance to achieve sustainable, scalable manufacturing performance. Manage packaging-related change controls, deviations, and CAPAs in collaboration with Quality; support root cause investigations related to packaging design or component performance. Evaluate and select packaging materials, components, and equipment in partnership with CMOs/CPOs and suppliers; support qualification of new suppliers and packaging lines. Provide packaging design expertise in support of the development of quality systems, processes, and procedures. Build, lead, and mentor a team supporting manufacturing package design activities (scope dependent on level). Provide subject matter expertise and support during regulatory inspections and audits related to packaging design and engineering. Domestic and international travel required ( approximately 10 –20%). Minimum Qualifications: Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred. 7+ years’ experience in sponsor-side manufacturing package design , with demonstrated leadership of packaging design programs. S ignificant experience supporting late-stage clinical and/or commercial packaging programs required . Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing. Demonstrated experience leading packaging technical strategy and design for late-stage /commercial programs, including technology transfer to commercial manufacturing. Experience managing relationships with CMOs/CPOs and packaging component/material suppliers. Working knowledge of drug substance , drug product , and packaging principles, equipment, and processes across solid dosage and/or parenteral formats. Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred. Experience with combination products/device packaging preferred, as applicable. Strong leadership, project management, and cross-functional collaboration skills; exercises judgment within broadly defined practices and policies in determining solutions and actions. Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success. Work Location: The (Associate) Director, Manufacturing Package Design role is based in the US, with occasional travel . ​ 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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. 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. 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $231,000 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. #WeAreLilly