Associate Director, Joint Process Team (JPT)

Company Information

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

• Headquarters: Indianapolis, Indiana
• Mission: Unite caring with discovery to make life better for people around the world.
• Values: Give our best effort, put people first.

Position Overview

The Associate Director, Joint Process Team (JPT) is responsible for leading a cross-functional team comprised of both Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives as part of the API External Manufacturing (API EM) site. This role provides leadership and functional-area expertise at the designated Contract Manufacturer site, in conjunction with API EM contract manufacturing personnel working at Lilly affiliate sites. The primary goal is to achieve the reliable and compliant manufacture of API drug substance that meets predetermined global quality standards.

The PIP role is a key business relationship owner with the Contract Manufacturer and is required to build & leverage relationships at all levels to ensure projects and materials are delivered on time and within downstream customer expectations. The Associate Director, JPT will partner with Lilly’s Process Research & Development group on commercialization (technology transfer, process validation and regulatory approval) of Lilly’s exciting leading pipeline and will be a member of the Flow Team.

Key Responsibilities

• Lead cross-functional Joint Process Teams to develop and achieve strategically aligned objectives (related to safety, quality, reliable supply and technology transfer) at the Contract Manufacturer.
• Lead internal process teams (IPTs) to enable successful completion of joint Lilly- Contract Manufacturer objectives.
• Successfully facilitate and champion quality, technical, and regulatory compliance at the Contract Manufacturer.
• Oversee production, batch release and shipment/supply chain schedules to ensure reliable supply.
• Facilitate Joint Steering Committee (JSC) meeting agendas with significant issues escalating from the JPT and strategic topics that require alignment from both Lilly and the Contract Manufacturer.
• Accountable for Contract Manufacturer performance metrics in line with Lilly’s Global Contract Manufacturing Standards.
• Liaise with senior management levels in Manufacturing, Quality, and other relevant departments.

Day-to-Day Production Support Responsibilities:

• Monitoring ongoing production support (e.g., production meeting attendance).
• Periodic housekeeping / fit & finish walk-throughs with area management.
• Tracking of resolution of identified issues.
• Practice vs. procedure walkthroughs with management.
• Leader of the Lilly process team and participate in applicable PLOTs.
• Effective management of internal and external stakeholders.
• Adhering to Lilly’s Business, Quality, and Financial Systems.

Requirements

• Strong understanding of manufacturing principles, operations, and project management is required.
• Knowledge of cGMPs and corporate/industry standards is essential.
• Ability to work cross-functionally within the site and with other functions to deliver on operational objectives.

Employment Details

• Employment Type: Full time

Location

• Location: Switzerland

Application Instructions

• Specific application instructions were not provided in the original description.