Operations Associate - Drug Product External Manufacturing

at  Lilly

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.

BASIC QUALIFICATIONS

• Master`s Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields
• Language spoken - fluent English.

ADDITIONAL SKILLS/ PREFERENCES

• Basic knowledge of parenteral processes
• Demonstrated experience aligning with delivering and assuring cGMP compliance of a production operation.
• Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
• Ability to represent Eli Lilly and Company’s mission, policies, and practices positively, professionally, and ethically and 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.
• Appreciation for cultural diversity

Responsible for working with the Contract Manufacturer(s) (CM) to support supply, quality, and continuous process improvement of medicines supplied to Lilly sites and the market. The Operations Associate is accountable to the Joint Process Team Leader.
Key Objectives/Deliverables:

To support ongoing CM Operations by providing 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 a 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 resolve issues 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, product, process, and equipment reviews.
• Develop effective and productive working relationships with colleagues at CM and Lilly sites.
• Lead cross-functional/cross-site/cross-company project teams as needed.
• Regularly visit CM to increase awareness of operations and maintain strong working relationships.
• 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’s product portfolio.
• Plan and execute product rationalization, termination, and market deletion when necessary.
• Provide backup, as appropriate, of the Joint Process Team Leader.