Lead Operator Molecule - Lilly Medicine Foundry

Lilly is a global healthcare leader aiming to make life better through discovery and advanced manufacturing. We are headquartered in Indianapolis, Indiana, and work worldwide to develop medicines, improve disease understanding, and contribute to communities through philanthropy and volunteerism. We seek people determined to make life better for others.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind will combine research and manufacturing to optimize processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact.

During the project delivery and startup phases (startup expected 2025 to 2027), operational roles will be fluid and dynamic as we support project delivery, build a new organization, implement the necessary systems and processes for GMP operations, and cultivate site culture. This will require collaboration, creativity, and resilience as the site scales to full GMP manufacturing during start-up.

The Lilly Medicine Foundry Manufacturing Lead Operator supports start-up activities to bring manufacturing equipment into service. The Lead Operator becomes an expert in their area, educating the team on proper operation of the facility. The role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. Upon completion of the project phase, the Lead Operator provides on-the-floor, tactical leadership for API production with a safety-first, quality-always mindset, managing a production process with diverse unit operations and manufacturing skills.

This role ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding a safety-first, quality-always mindset. Lead Operators will support daily activities to meet production plans by:

• Help enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalate any adverse events.
• Operate processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet the production schedule.
• Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift.
• Ensure completion of daily monitoring, testing, and cleaning duties to keep equipment and systems in good operating condition and maintained per local and corporate regulatory requirements.
• Serve as a cultural leader for site safety, promoting compliant operations and positive safety behaviors. Lead by example and promote accountability at all levels.
• Provide technical leadership for troubleshooting and responding to process upsets, integrating operator input and escalating as appropriate.
• Follow all applicable procedures for safety event reporting and documentation, including spill response, issue escalation, and Emergency Response procedures as needed.
• Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to align on daily operational goals.
• Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements for the work area.
• Partner with area management to understand Foundry strategy and future production needs, and represent this strategy in conversations with shift members.
• Actively participate in building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Use provided PPE (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats) as required.

• HS Diploma/GED
• 3+ years of directly applicable manufacturing experience; GMP and/or chemical processing strongly preferred.
• Legal authorization to work in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN).

• Previous experience in facility or area startup environments.
• Experience in pharmaceutical or chemical manufacturing involving PSM-regulated or hazardous chemicals.
• Solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• Ability to understand technical nomenclature and language, and work with mathematical formulas.
• Effective communication skills (electronic, written, verbal).
• Basic computer skills (desktop software) are required.

• Position Location:
  
  US:
  Lebanon IN;
  Lilly Medicine Foundry Operations (initial location in Indianapolis, IN during pre-startup)
• Travel Percentage: 5%
• Must be able to work a…