Manager - Drug Product External Manufacturing - Parenteral Operations

Eli Lilly and Company•Indianapolis, IN

1d•$65,250 - $145,200

About The Position

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 manufacturing supply, quality, and continuous process improvement of parenteral 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 Parenteral 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 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. At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Requirements

Bachelor`s Degree or equivalent work experience in Engineering, Pharmacy, Chemistry, or similarly related fields.
2+ years of experience supporting pharmaceutical manufacturing operations

Nice To Haves

Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
Parenteral manufacturing experience in drug product formulation, filling and visual inspection processes
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.
Experience leading cross functional teams
Solid technical writing skills.
Proven ability to organize and prioritize multiple tasks.

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 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

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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