Lead Operator Small Molecule - Lilly Medicine Foundry

Responsibilities

• Support start-up activities to bring manufacturing equipment into service.
• Become an expert in assigned area and educate the team on proper operation of the facility.
• Ensure the supply of medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding a safety-first, quality-always mindset.
• Lead operators to meet production plans by:
• Enforce adherence to compliance requirements (safety, quality, and environmental).
• 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 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, sing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per 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.
• Ensure adequate communication 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. Represent and support 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) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.

Requirements

• HS Diploma/GED
• 3+ years of directly applicable manufacturing experience, GMP and/or chemical processing strongly preferred.

Qualifications

• Authorized to work in the United States on a full-time basis.
• Knowledge of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• A solid understanding 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.
• Able to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.