Lead Operator - Peptide Synthesis

Role Summary

The Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. The Lead Operator will uphold a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations. During the project delivery and startup phases (startup expected 2025 to 2027), roles will be fluid and dynamic as the site builds GMP operations and a culture supportive of startup growth.

Responsibilities

• Maintain compliance with all regulatory requirements at all times.
• Support the execution of the production plan for the site.
• Carry out daily monitoring testing and cleaning duties as assigned on the listed systems to ensure equipment and systems are in good operating conditions and maintained in accordance with local and corporate regulatory requirements.
• Enter Trackwise events, participate in and lead CAPA investigations
• Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact
• Understand Health, Safety & Environmental-regulated environment and apply Health & Safety/Process Safety standards to execute key/critical GMP duties.
• Understand other area processes and their operational hazards and react appropriately.
• Monitor and collect data on equipment use and performance to anticipate potential reliability problems.
• Work with Maintenance and Technical Support to respond to potential utility supply upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communicate to other shifts regarding status of area operations and details of issues at handover.
• Participate in safety audits, procedure coordination, housekeeping and improvement projects.
• Be trained and qualified on all specified unit operations within the building.
• Identify concerns for informal or formal discussion (shift meetings, safety representative).
• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area.

Qualifications

• Required: High School Diploma or equivalent
• Required: Legally authorized to be employed in the United States; no anticipated sponsorship for employment visa status
• Required: Completion of Post Offer Exam or Completion of Work Simulation if applicable
• Required: Ability to effectively communicate electronically, in writing and verbally
• Required: Basic computer skills (desktop software)
• Required: Minimum 3 years previous experience in operations
• Preferred: Previous experience in facility/area startup environments
• Preferred: Previous experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals
• Preferred: Ability to assume leadership and prioritize daily priorities without direct supervision
• Preferred: Solid understanding of FDA guidelines and cGMP requirements
• Preferred: Strong organizational skills and ability to handle multiple requests
• Preferred: Knowledge of lean manufacturing principles
• Preferred: Flexibility to troubleshoot and triage challenges
• Preferred: Ability to understand technical nomenclature and language and work with mathematical formulas
• Preferred: Manual material handling as appropriate
• Preferred: Bend, reach, stretch, climb ladders, and work in tight spaces; stand for long periods

Additional Requirements

• Ability to work rotating 12-hour day or night shifts
• Ability to work flexible schedules during startup period
• Ability to work overtime as required