Associate / Sr. Associate / Manager - Drug Product External Manufacturing Operations

Associate / Sr. Associate / Manager - Drug Product External Manufacturing Operations page is loaded## Associate / Sr. Associate / Manager - Drug Product External Manufacturing Operationslocations : US, Indianapolis INtime type : Full timeposted on : Posted Todayjob requisition id : R-94202At 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. Responsibilities Responsible for working with the Contract Manufacturer(s) (CM) to support supply, quality, and continuous process improvement of 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 Operations by providing an oversight at the Joint Process Team : Facilitate the Joint Process Team between Lilly and the Contract Manufacturer. Monitor and communicate monthly JPT metrics. Support Huddles with focus on KPIs with JPT Members. Foster and Support Strong Safety and Quality Cultures at the CMs.

• Support Launch / Divestiture Activities as needed.
• Provide day to day oversight of activities and resolution of issues taking place between the CMs and Lilly.
• Lead the resolution of manufacturing related issues including deviations / complaints and evaluation of manufacturing data and supply chain needs.
• 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.
• Develop effective and productive working relationships with colleagues at CM sites and at Lilly sites.
• Lead cross-functional / cross-site / cross-company project teams as needed.
• Make regular visits to CM to increase awareness of operations and maintaining strong working relationship.
• 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.
• Support external and internal audits performed at the CM related to Lilly product portfolio.
• Plan and execute product rationalization, termination, and market deletion when necessary.
• Provide backup, as appropriate, of the Joint Process Team LeaderRelationship with the CM :
• Make regular visits to CM to increase awareness of operations and maintaining strong working relationship.
• Manage conflict and problem resolution.
• Support external and internal audits performed at the CM related to Lilly product portfolio.
• Plan and execute product rationalization, termination, and market deletion when necessary.Others :
• All key relevant functions at the contract manufacturers.
• Drug product External manufacturing leadership.
• Lilly Manufacturing Procurement.
• Network within Lilly manufacturing sites to support the role and the relationship. Basic Qualifications
• Bachelor`s Degree or equivalent work experience in Engineering, Pharmacy, Chemistry, or similarly related fields.
• 2+ years of experience supporting manufacturing Additional Skills / Preferences
• Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
• Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
• Parenteral manufacturing experience
• Ability to represent Eli Lilly's mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• A thorough understanding of cGMPs and drug product manufacturing.
• Strong communication (written and oral) skills, teamwork, and influence.
• Solid technical writing skills.
• Proven ability to organize and prioritize multiple tasks. Additional Information
• Travel is required for CM support and Business reviews, up to 30%.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), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate's 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 Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLillyAt Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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