Lead Operator, Biologics - Medicine Foundry

Eli Lilly and Company • Us, IN

3d • Onsite

About The Position

The Lead Operator provides on-the-floor tactical leadership for the production of API molecules at the Lilly Medicine Foundry, ensuring a safety-first, quality-always approach across diverse unit operations and manufacturing skills. During the startup phase this role actively supports startup activities to bring manufacturing equipment into service, becoming an area expert and educating the team on proper facility operations, including domestic and international travel to collaborate with and learn from existing API production sites. Upon completion of the project phase, the Lead Operator ensures safe, compliant, and efficient daily production by following batch records, SOPs, and work instructions while managing shift operations and supporting continuous improvement initiatives.

Requirements

• High School Diploma or GED equivalent.
• 3+ years of directly applicable manufacturing experience; GMP and/or chemical processing experience strongly preferred.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Proficient in basic computer skills (desktop software) with the ability to understand technical nomenclature and language and work with mathematical formulas.
• Prior work with FDA guidelines and cGMP requirements, with a solid understanding of compliance expectations in a GMP manufacturing environment.
• Proven ability to troubleshoot and triage manufacturing challenges effectively, with strong organizational skills and the ability to prioritize multiple requests simultaneously.
• Strong organizational skills and ability to handle and prioritize multiple requests.

Nice To Haves

• Prior experience in facility or area startup environments and/or pharmaceutical or chemical manufacturing operations involving PSM-regulated or hazardous chemicals.
• Demonstrated knowledge of Lean Manufacturing principles; ability to effectively communicate electronically, in writing, and verbally; and flexibility to support operations outside of normal working hours.
• Strong technical proficiency and ability to train and mentor others.

Responsibilities

• Provide on-the-floor tactical leadership to make day-to-day decisions and ensure proper prioritization of operations resources throughout the shift; operate processes and equipment according to batch records, user manuals, SOPs, and work instructions to meet the production schedule; and enforce adherence to safety, quality, and environmental compliance requirements, escalating any adverse events appropriately.
• Serve as a cultural leader for site safety culture; promote compliant operations and positive safety behaviors; lead by example; provide technical leadership for troubleshooting and reaction to process upsets; follow all procedures for safety event reporting and documentation; and initiate Emergency Response procedures as needed.
• Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings; ensure completion of daily monitoring, testing, and cleaning duties; ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements; and actively participate in safety audits, procedure coordination, and continuous improvement projects.
• Partner with area management to understand Foundry strategy and future production needs; represent and support this strategy in conversations with shift members; use specified company-supplied PPE as required; and support daily activities to meet the production plan by collaborating cross-functionally.
• During startup actively support startup activities to bring manufacturing equipment into service; become the area SME and educate the team on proper facility operations; and participate in domestic and international travel to collaborate with and learn from API production sites.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• 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