Associate/Sr. Associate/Manager - Drug Product ...
Lilly - Indianapolis, IN
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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. Weu2019re looking for people who are determined to make life better for people around the world. Responsibilities Responsible for working with the Contract Manufacturer(s) (CM) to support manufacturing supply, quality, and continuous process improvement of parenteral products that are supplied to Lilly sites and the market. The Operations Associate is accountable to the Joint Process Team Leader. Key Objectives/Deliverables: To support on-going CM Parenteral Operations by providing an oversight at the Joint Process Team: u00b7 Facilitate the Joint Process Team between Lilly and the Contract Manufacturer. u00b7 Monitor and communicate monthly JPT metrics. u00b7 Support Huddles with focus on KPIs with JPT Members. u00b7 Foster and Support Strong Safety and Quality Cultures at the CMs. u00b7 Support Launch/Divestiture Activities as needed. u00b7 Provide day to day oversight of activities and resolution of issues taking place between the CMs and Lilly. u00b7 Lead the resolution of manufacturing related issues including deviations/complaints and evaluation of manufacturing data and supply chain needs. u00b7 Track timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews. u00b7 Develop effective and productive working relationships with colleagues at CM sites and at Lilly sites. u00b7 Lead cross-functional/cross-site/cross-company project teams as needed. u00b7 Make regular visits to CM to increase awareness of operations and maintaining strong working relationship. u00b7 Manage conflict and problem resolution. Facilitate Lilly/CM Steering Team meeting agendas, with issues from the JPT requiring Steering Team actions. Present and document the decisions in Steering Team minutes. u00b7 Support external and internal audits performed at the CM related to Lilly product portfolio. u00b7 Plan and execute product rationalization, termination, and market deletion when necessary. u00b7 Provide backup, as appropriate, of the Joint Process Team Leader Relationship with the CM: u00b7 Make regular visits to CM to increase awareness of operations and maintaining strong working relationship. u00b7 Manage conflict and problem resolution. u00b7 Support external and internal audits performed at the CM related to Lilly product portfolio. u00b7 Plan and execute product rationalization, termination, and market deletion when necessary. Others: u00b7 All key relevant functions at the contract manufacturers. u00b7 Drug product External manufacturing leadership. u00b7 Lilly Manufacturing Procurement. u00b7 Network within Lilly manufacturing sites to support the role and the relationship. Basic Qualifications u00b7 Bachelor`s Degree or equivalent work experience in Engineering, Pharmacy, Chemistry, or similarly related fields. u00b7 2+ years of experience supporting pharmaceutical manufacturing operations Additional Skills/ Preferences u00b7 Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation. u00b7 Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools. u00b7 Parenteral manufacturing experience in drug product formulation, filling and visual inspection processes u00b7 Ability to represent Eli Lillyu2019s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs. u00b7 A thorough understanding of cGMPs and drug product manufacturing. u00b7 Strong communication (written and oral) skills, teamwork, and influence. u00b7 Experience leading cross functional teams u00b7 Solid technical writing skills. u00b7 Proven ability to organize and prioritize multiple tasks. Additional Information u00b7 Travel is required for CM support and Business reviews, up to 30%. u00b7 Position is based in Indianapolis, IN u00b7 Off- shift/after hours support may be required 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 ( ) 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 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), Womenu2019s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidateu2019s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $145,200 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 Lillyu2019s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
Created: 2026-01-08