Lead Operator Small Molecule - Lilly Medicine Foundry

Lilly Medicine Foundry Manufacturing Lead Operator

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.

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.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), operational roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

Job Position Overview:

The Lilly Medicine Foundry Manufacturing Lead Operator actively supports start-up activities to bring manufacturing equipment into service. The Lead Operator becomes an expert in their assigned area and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs.

Upon completion of the project phase, the Lead Operator provides on-the-floor, tactical leadership for production of API molecules. The Lead Operator ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills.

Responsibilities:

This role ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding our safety-first, quality-always mindset. Lead Operators will support daily activities to meet production plans by:

• Responsible to help enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events.
• Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
• Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift.
• Ensure completion of daily monitoring, testing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
• Serve as a cultural leader for site safety culture, promoting compliant operations and positive safety behaviors. Lead by example and promote accountability at all levels.
• Provide technical leadership for troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
• Follow all applicable procedures for safety event reporting and documentation. This includes following appropriate spill response procedures, escalation of issues, and initiating Emergency Response procedures as needed.
• Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Ensure all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Partner with area management and supervision to understand Foundry strategy and future production needs. Represent and support this strategy in conversations with shift members.
• Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Using specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.

Basic Requirements:

• HS Diploma/GED
• 3+ years of directly applicable manufacturing experience, GMP and/or chemical processing 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.

Additional Skills/Preferences:

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

Additional Information:

• Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 5%
• Must be able to work a 12-hour rotating shift
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $25.96 - $38.08.