Sr. Principal Project Manager – API 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.

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. 

Position Description:

The CMC Project Management Professional is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) activities for our pharmaceutical products. This role requires a strong background in managing pharmaceutical projects and new facility start-ups, with a focus on ensuring compliance with Good Manufacturing Practices (GMPs). This position will lead the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial product manufacturing knowledge, leadership and business acumen, and project management skills. The Project Manager must have strong relationship and communication skills and an ability to influence team members and leadership at manufacturing sites, within core Manufacturing and Quality (M&Q) functions, and within the relevant Business Unit.  A person in this position has a CMC and/or manufacturing background and is expected to apply project management principles as guided by PMBOK, including robust risk management for cross-functional teams. 

Key Objectives/Deliverables

• Work closely with technical leadership to actively manage pharmaceutical manufacturing projects, facilitate project reviews to ensure processes are in control and capable, and lead teams to ensure on time delivery of projects.

  • Responsible for project schedule for tech transfer of products across sites within Eli Lilly, including process validation and commercialization of manufacturing processes for active pharmaceutical ingredients.

  • Manage the planning, coordination, and execution of new facility start-up activities, including process and cleaning validation.

  • Work closely with SMEs in Process Chemistry, Peptide Synthesis/Purification, Materials, Engineering, Manufacturing and Quality to manage impact of project changes.

  • Maintain technical knowledge of project.

• Implement and improve standard business management processes such as capacity/budget estimation, planning, allocation, and tracking. Forecast resource needs and manage allocated budgets.

• Identify, propose, and support solutions for operational problems and technical challenges.  Ensure project management is appropriately represented and involved in cross-functional process improvement projects.

• Ensure all CMC activities comply with GMP regulations and guidelines, maintaining high standards of quality and safety.

Project Management expertise: 

• Applies knowledge of project management tools and processes. 

  • Drives team decision making process to resolve project issues. Able to influence decisions at all levels of the company. Demonstrated ability to influence without authority.

  • Demonstrated ability to work with ambiguity and to "connect the dots"

  • Develops a risk management strategy for individual projects and ensures contingency plans are developed. 

  • Evaluates new requests for manufacturing or product changes for p