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

Role Summary

Associate/Sr. Associate/Manager responsible for collaborating with contract manufacturers to support manufacturing supply, quality, and continuous process improvement of parenteral drug products, and for oversight of the Joint Process Team activities between Lilly and contract manufacturers. The role includes day-to-day oversight of CM operations, cross-functional collaboration, and ensuring alignment with quality and regulatory requirements.

Responsibilities

• 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 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 procedural changes, audits, investigations, and reviews.
• Develop effective working relationships with CM and Lilly sites.
• Lead cross-functional/cross-site/cross-company project teams as needed.
• Make regular visits to CM to maintain awareness of operations and strengthen relationships.
• Manage conflict and problem resolution; facilitate Steering Team meeting agendas and document decisions.
• Support external and internal audits at the CM related to Lilly products.
• Plan and execute product rationalization, termination, and market deletion when necessary.
• Provide backup support as appropriate for the Joint Process Team Leader.

Qualifications

• Required: Bachelor’s Degree or equivalent in Engineering, Pharmacy, Chemistry, or related field; 2+ years of experience in pharmaceutical manufacturing operations.
• Preferred: Experience aligning with cGMP compliance, SPC and Six Sigma/Lean tools; parenteral manufacturing experience in drug product formulation, filling, and visual inspection; strong communication, teamwork, and cross-functional leadership; solid technical writing skills; ability to organize and prioritize multiple tasks.

Education

• Bachelor’s Degree or equivalent in Engineering, Pharmacy, Chemistry, or related field.

Additional Requirements

• Travel is required for CM support and business reviews, up to 30%.
• Position based in Indianapolis, IN.
• Off-shift/after-hours support may be required.