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 safety-first, quality-always mindset.
• Manage daily activities to meet production plans by:
• Enforcing compliance with safety, quality, and environmental regulations and escalating adverse events.
• Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions.
• Making tactical day-to-day decisions and ensuring proper prioritization of operations resources.
• Ensuring daily monitoring, sanitizing, and cleaning duties are completed to maintain equipment and systems in good condition.
• Providing on-the-floor leadership to ensure a safety-first, quality-always approach.
• Leading troubleshooting and reacting to process upsets, integrating operator input, and escalating as necessary.
• Reporting and documenting safety events in accordance with procedures.
• Communicating shift passovers and participating in daily shift huddles/meetings.
• Ensuring all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements.
• Partnering with area management and supervision to understand Foundry strategy and future production needs.
• Representing and supporting the strategy in conversations with shift members.
• Participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.

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.
• 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.
• Able to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.