Advisor – Technical Operations – Lilly Medicine Foundry

Eli Lilly and Company • Lebanon, IN

23h • $129,000 - $209,000 • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization and Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Lilly Medicine Foundry Advisor/Sr Advisor – Technical Operations will provide technical mentorship and administrative leadership for the operations technical team. This team supports operations activities to ensure effective and consistent execution on the operation floor. The team provides on-floor support, works directly with operators, supports batch readiness and release, and works cross-functionally to provide technical and operational oversight to routine operations. Advisor/Sr Advisor – Technical Operations serves as a key operations leader working with Process Engineering, Process Translation and Execution (PTE), and Product Research and Development (PRD) in providing a consistent and repeatable approach introducing new processes into the plant. In the pre-startup phase, Advisor/Sr Advisor – Technical Operations will contribute heavily to Operational Readiness preparations for the new facility, such as creation/delivery of trainings, procedures, and workflows to support future Foundry needs and operating plans. This role will be involved in the area C&Q activities providing technical leadership during the pre-start-up phase. This role will serve as a key leader in the tech transfer and new product introduction process, providing key technical and operational guidance. Upon completion of the project phase, the Advisor/Sr Advisor – Technical Operations will be a member of the Operations Area Lead Team delivering technical leadership for the operations team to ensure right first-time execution, on the floor process support, and routine process or equipment troubleshooting. This role will be responsible to lead one or more of the operations equipment unit teams. This role plays a key technical role working collaboratively with the Process Translation and Execution (PTE), Processing Engineering (PE) and Product Research and Development (PRD) to prepare for effective delivery of our products. This role ensures consistent technical input and participation in pre-startup activities such as Process Hazard Reviews (PHRs), development batch instructions, and on the floor operations support. The Advisor/Sr Advisor – Technical Operations ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills. This role may require domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Requirements

• BS in science, engineering, or technical field with 12+ years of experience in pharmaceutical or chemical manufacturing operations involving PSM-regulated or hazardous chemicals, or MS with 10 years of experience, or PhD with 2 years of experience.
• Minimum of 5+ years of experience providing technical leadership in Operations, Process Translation and Execution, Processing Engineering or Product Research and Development

Nice To Haves

• Experience in clinical API GMP production
• Experience in pharmaceutical Product Research and Development
• Formal project management training considered a plus
• Demonstrated leadership and influencing experience
• Experience in facility or area start-up environments
• A solid understanding of FDA guidelines and cGMP requirements
• Strong organizational skills with the ability to handle competing priorities
• 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

Responsibilities

• Provide technical and administrative leadership of engineers and scientists for the Technical Operations team
• Participate as part of the Operations Lead Team, driving consistency and technical excellence for the operations function
• Ensure on the floor support for training and process support from the Technical Operations team.
• Collaborate with Process Engineering (PE) and Process Translation and Execution (PTE) with manufacturing technical input
• Lead Safety and Quality Investigations while ensuring consistency and thoroughness of those authored by the team.
• Serve as a key technical resource for operational improvement projects and other initiatives.
• Lead of one or more of the operations equipment unit teams ensuring on time execution project plans for all phases of process campaigns.
• Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards and ensure effective operations representation in Process Hazard Review (PHR) meetings and other HSE-related venues.
• Promote continuous improvement of area changeover workflows to make changeovers easier or more efficient.
• This role will support one of the three operations areas (based on candidate background) at the Lilly Medicine Foundry (Small Molecule, Biologics, or Mixed Modalities) while working with peers in the other areas to share consistent best practices across the site’s operations areas

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and 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