Operations Supervisor (Parenteral Filling)

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 35,000 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 Overview
For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
Responsibilities
During the project phase, the Operations Supervisor – Parenteral Filling will support commissioning/qualification activities required to bring filling lines, utilizing isolator technology, into service as well as supporting site operational readiness activities. This position will require domestic travel with the opportunity for international travel based on program need. This role is expected to be an on-the-floor leader and will be a subject matter expert for the filling process. This role will have the opportunity to be directly involved with hiring their team.
After project phase completion, the Operations Supervisor – Parenteral is responsible for shift leadership for multiple drug product filling lines within the area and developing the technical expertise of manufacturing employees. This individual must ensure that the manufacturing lines are adequately staffed with trained/qualified employees. Strict adherence to safety and quality rules and procedures is required. Direct line supervision for line leaders and operators on a 12 hour shift rotation schedule.
Key Objectives

• Communicate with the area Manager on quality, equipment, and operational issues and areas for improvement.
• Responsible for shop floor execution as it relates to business plan, current Good Manufacturing Practice (CGMP) conformance and Operational Standards for Supply Chain Excellence (OSSCE)
• Ensures adequate qualified/trained staffing for operators working on the manufacturing lines.
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE goals.
• Responsible for hiring/managing 10+ direct reports working across 2 manufacturing lines.
• Support Site Leadership to build a diverse, inclusive, and capable site organization by delivering area operational procedures, quality processes and controls for Parenteral areas.
• Act as both administrator and technical leader for operations, setting a good example through demonstrated knowledge of procedures, compliance with quality systems and use of proper technique.
• Collaborate with support functions to achieve a consensus for unexpected events during manufacturing.
• Responsible for the coaching, development, and performance evaluation of operators/technicians.
• Originate/Investigate deviations or operational quality issues.

Basic Requirements

• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Solid understanding of FDA guidelines and CGMP requirements.
• High School Diploma or equivalent

Additional Preferences

• Strong organizational skills and ability to handle and prioritize multiple requests.
• Excellent interpersonal, written and oral communication skills
• Previous experience working in a CGMP environment
• Bachelor’s Degree in science, engineering, or technical field
• Basic computer skills (desktop software) are required.
• Skills in providing/receiving feedback and creating employee development plans
• Strong technical aptitude and ability to train and mentor others.
• Previous experience in facility/area start-up environments
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Demonstrated leadership experience
• Experience with root cause analysis/technical writing
• Knowledge of lean manufacturing principles
• Organizational and motivational skills
• Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.

Additional Information

• Ability to work 12 hour day shifts (2-2-3 schedule)
• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.
• Ability to work overtime as required
• Position may require a short duration assignment of 2-6 months in Indianapolis to establish specific device knowledge, establish global contacts, and provide production support. Additionally, this position may require short (less than 1 month) international travel to support Factory Acceptance Testing of equipment.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
• Ability to travel up to 20% during the startup phase, process training, and < 5% after startup

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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