Associate Director - Joint Process Team Leader Drug Product External Manufacturing

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:

Drug Product External Manufacturing (DPEM) is responsible for making medicine at contract manufacturers located globally, selected by Lilly to make drug product that will bear the Lilly brand.  DPEM manages technical, quality, supply and financial aspects of all issues with the contract manufacturers and alliances who supply product to Lilly to ensure risks to Lilly in manufacturing product outside Lilly is appropriate and provides optimum protection to the Lilly brand.

Responsibilities:

The Joint Process Team Leader (JPTL) is the externally facing business owner for the relationship between Lilly and a contract manufacturer and provides leadership to the cross-functional Joint Process Team (JPT). This JPTL role will provide leadership for U.S. based contract manufacturer relationships.

Support On-Going Contract Manufacturer Operations by providing leadership and oversight at the Joint Process Team

• Leads cross-functional JPT, between Lilly and contract manufacturer, to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the contract manufacturer.

• Accountable for the governance process over the contract manufacturer and the monitoring of quality, safety, business and technical metrics, identifying areas of concern or risk, generating CAPA’s and improvement plans and timely escalation of issues.

• Plan and execute product rationalization, contract termination and market deletion when necessary.

• The JPTL may have project leadership responsibilities for establishment of a new product/Contract Manufacturer.

Relationship with Contract Manufacturer (CM)
• 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 with issues from the JPT requiring Steering Team actions.

• Support internal and external audits performed at the CM related to the Lilly product portfolio

Basic Requirements:

• Bachelors Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields
• Minimum 4 years of experience supporting pharmaceutical manufacturing

Additional Skills/Preferences:

• Experience as a process team leader
• Experience in Statistical Process Control (SPC) and Six Sigma Tools (e.g. Green Belt certification) or Lean Tools

• Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment

• Capability to work in a virtual and complex environment across different cultures

• A thorough understanding of cGMPs

Additional Information:
• Travel up to 30%
• Day Shift, but off hours may be necessary to support operations

• This role will need to be onsite, in the office, the majority of the time.

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