Advisor - Project Manager - TS/MS

Eli Lilly and Company • Lebanon, IN

1d • $117,000 - $209,000 • Onsite

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. 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. The CMC Project Manager role leads the creation, development, communication, and implementation of integrated technology transfer plans from portfolio entry through global submissions, approvals, and launch. The position applies project management principles, ensures compliance with GMP regulations, and drives operational excellence across cross-functional teams. The CMC Project Manager demonstrates leadership, business acumen, and strong relationship-building skills to influence stakeholders at manufacturing sites, within Manufacturing and Quality (M&Q) functions, and across the Business Unit.

Requirements

• Education Level: BSc or MSc in a scientific or engineering field or Master’s in Project Management.
• Experience: 5+ years of pharmaceutical experience in drug discovery/process development, material supply chain, CMC, quality, or commercial manufacturing.

Nice To Haves

• Experience in Operations, Technical Services / Manufacturing Science (TS/MS), QA/QC, Regulatory, or Supply Chain within pharmaceutical manufacturing.
• Technology transfer experience.
• Successful leadership of cross-functional teams.
• Ability to identify and prioritize problems, develop and implement solutions.
• Strong interpersonal, teamwork, and organizational skills, and ability to rapidly integrate into an existing team preparing for plant startup and commercial readiness.
• Excellent oral and written communication skills for all organizational levels.
• Ability to manage changing priorities within tight timelines.

Responsibilities

• Manage pharmaceutical technology transfer projects and facilitate project reviews to ensure processes remain well-controlled and capable.
• Lead teams to deliver projects on time and within scope.
• Maintain project schedules for tech transfer of products across sites, including process validation and commercialization of manufacturing processes for API.
• Collaborate with SMEs on new facility start-up activities, including process and cleaning validation.
• Collaborate with SMEs in Process Chemistry, Peptide Synthesis/Purification, Materials, Engineering, Manufacturing, and Quality to manage project impacts.
• Implement and improve business management processes such as capacity/budget estimation, planning, allocation, and tracking.
• Forecast resource needs and manage allocated budgets.
• Identify and resolve operational and technical challenges; represent project management in cross-functional process improvement initiatives.
• Ensure all CMC activities comply with GMP regulations and guidelines
• Promote a safe working environment by adhering to safety protocols and actively contributing to safety culture initiatives.

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level