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.

Organization Overview
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.

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 (JPT) 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.

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.
• Minimum 2-3 years of relevant experience, Parenteral manufacturing experience preferred.

Additional Skills/ Preferences

• Demonstrated experience aligning with delivery of and assuring c GMP compliance of a production operation.
• 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 c GMPs 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.
• Appreciation for cultural diversity.
• Language spoken - fluent English.

Additional Information

• Travel is required for CM support and Business reviews, up to 30%.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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