Job Information
Lilly Operations Associate - Drug Product External Manufacturing - Device Assembly/Packaging in Indianapolis, Indiana
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.
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 Leader.
Relationships:
Relationship 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.
Other:
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 in Engineering, Pharmacy, Chemistry, or similarly related fields.
2-5 years of pharmaceutical GMP manufacturing experience.
Additional Skills/ Preferences
Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
Experience in robotic assembly and/or packaging operations.
Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
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.
Capability to work in a virtual and complex environment.
Additional Information
Requires on site presence in Indianapolis and is not a remote position.
Travel is required for CM support and Business reviews, up to 50%.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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