Lead Chemical Operator - Peptide Synthesis

Lilly • Lebanon, IN

7d • Onsite

About The Position

Lilly is a global healthcare leader dedicated to uniting caring with discovery to improve lives worldwide. The company is constructing an advanced manufacturing facility in Lebanon, IN, for the production of API (Active Pharmaceutical Ingredient) molecules, representing Lilly's largest investment in manufacturing capacity. This facility will produce APIs for current and future products, including new modalities. This is a unique opportunity to join the startup team for a greenfield manufacturing site, contributing to building processes and the facility for successful GMP manufacturing operations.

The Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. This role requires a safety-first, quality-always mindset while running a production process that incorporates a wide range of unit operations.

During the project delivery and startup phases (expected 2025 to 2027), the role will be dynamic, supporting project delivery, building a new organization, developing and implementing necessary systems and business processes for GMP operations, and fostering the site culture. This will require significant collaboration, creativity, and resilience as the site scales to full GMP manufacturing.

Requirements

• High School Diploma or equivalent
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• 3+ years chemical processing experience or equivalent comparable manufacturing experience

Nice To Haves

• Previous experience in facility/area start-up environments
• Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals
• Ability to assume leadership and prioritize daily priorities without direct supervision
• Solid understanding of FDA guidelines and cGMP requirements
• Strong organizational skills and ability to handle and prioritize multiple requests
• Knowledge of lean manufacturing principles
• Flexibility – ability to troubleshoot and triage challenges
• Ability to understand technical nomenclature and language as well as work with mathematical formulas
• Manual material handling as appropriate
• Bend, reach, stretch, climb ladders, and work in tight spaces
• Stand for long periods

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 above listed systems to ensure equipment and systems are in good operating conditions and they are 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 application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond appropriately 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 the status of the area operations and details of any issues/problems that have occurred at handover.
• Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, 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 and job classification.
• Ability to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.

Benefits

• company bonus (depending, in part, on company and individual performance)
• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED