Lead Operator, Hybrid Operations - Lilly Medicine Foundry

About the role

The Lilly Medicine Foundry Manufacturing Lead Operator supports start-up activities to bring manufacturing equipment into service. They become an expert in their assigned area and educate the team on proper operation of the facility. This role involves domestic and international travel to collaborate, train, and learn from sites producing APIs. After completing the project phase, the Lead Operator leads production of API molecules on-site, ensuring a safety-first, quality-always approach.

Responsibilities

• Support daily activities to meet production plans by enforcing compliance, assisting with troubleshooting, and collaborating cross-functionally.
• Ensure adherence to compliance requirements (safety, quality, and environmental) and escalate adverse events.
• Operate processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet 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 maintain equipment and systems in good operating condition and comply with local and corporate regulatory requirements.
• Serve as a cultural leader for site safety culture, promoting compliant operations and positive safety behaviors.
• Lead by example and promote accountability at all levels.
• Provide technical leadership for troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
• Follow all applicable procedures for safety event reporting and documentation, including spill response procedures, escalation of issues, and initiating Emergency Response procedures as needed.
• Adequately communicate at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Partner with area management and supervision to understand Foundry strategy and future production needs, representing and supporting this strategy in conversations with shift members.
• Participate in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Use specified company-supplied personal protective equipment (PPE) as required.

Requirements

• HS Diploma/GED
• 3+ years of directly applicable manufacturing experience, GMP and/or chemical processing strongly preferred
• 2 years of direct leadership/supervisory experience required
• API experienced required

Qualifications

• Authorized to work in the United States on a full-time basis
• Previous experience in facility or area start-up environments
• Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals
• A 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
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas
• Ability to effectively communicate (electronically, written and verbal)
• Basic computer skills (desktop software) are required