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

Role Summary

Associate/Sr. Associate/Manager - Drug Product External Manufacturing Operations. Responsible for working with Contract Manufacturer(s) to support supply, quality, and continuous process improvement of products supplied to Lilly sites and the market. The Operations Associate is accountable to the Joint Process Team Leader.

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, reviews, and equipment 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 increase awareness of operations and maintain strong relationships.
• Manage conflict and problem resolution. Facilitate Steering Team agendas and document decisions.
• Support external and internal audits at the CM related to Lilly product portfolio.
• Plan and execute product rationalization, termination, and market deletion when necessary.
• Provide backup for the Joint Process Team Leader as appropriate.

Qualifications

• Bachelor's Degree or equivalent work experience in Engineering, Pharmacy, Chemistry, or related fields.
• 2+ years of experience supporting manufacturing.

Skills

• cGMP compliance of production operations; experience in SPC and Six Sigma or Lean Tools (preferred).
• Parenteral manufacturing experience (preferred).
• Ability to represent Lilly‚Äôs mission, policies, and practices professionally and to influence CMs.
• Thorough understanding of cGMPs and drug product manufacturing.
• Strong written and oral communication, teamwork, and influence; solid technical writing skills.
• Ability to organize and prioritize multiple tasks.

Education

• As listed in Qualifications: Bachelor's Degree or equivalent work experience in related fields.

Additional Requirements

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