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 Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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:

This role is expected to be an on-the-floor leader and will be a subject matter expert for the material preparation (parts washing, material preparation, and autoclave) process. This role will have the opportunity to be directly involved with hiring and training their team. Based on general production schedule, the Operations Supervisor is expected to generate detailed hour-by-hour schedule for the area to support parenteral operations.

The Operations Supervisor is responsible for shift leadership for multiple drug product material preparation teams within the area and developing the technical expertise of manufacturing employees. This individual must ensure that the operations 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 schedule (2-2-3).

Key Objectives

• Support Site Leadership to build a diverse, inclusive, and capable site organization by delivering area operational procedures, quality processes and controls for Parenteral areas.

• Responsible for hiring/managing 10+ direct reports working across 2 material preparation suites.

• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE goals.

• Ensures adequate qualified/trained staffing for operators working on the manufacturing lines.

• Communicate with the area Manager on quality, equipment, and operational issues and areas for improvement.

• Responsible for the coaching, personal development, and performance evaluation of operators/technicians.

• Originate/Investigate deviations or operational quality issues.

• Collaborate with support functions to achieve a consensus for unexpected events during manufacturing.

• Collaborate with support functions to update and approve Standard Operating Procedures for site start up.

• 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.

• 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)

Basic Requirements:

• High School Diploma or equivalent

Additional Skills/Preferences:

• Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.

• Demonstrated leadership experience

• Skills in providing/receiving feedback and creating employee development plans

• Basic computer skills (desktop software) are required.

• Solid understanding of FDA guidelines and CGMP requirements.

• Excellent interpersonal, written and oral communication skills

• Strong organizational skills and ability to handle and prioritize multiple requests.

• Strong technical aptitude and ability to train and mentor others.

• Ability to work 12-hour shifts (2-2-3 schedule) with ability to work overtime as required.

• Ability to work in a controlled environment (classified and non-classified) which requires specific company provided gowning.

• Ability to travel up to 100% during Asset Delivery, process training, and < 5% after startup

• Ability to train on day shift for up to 1-2 months.

• Bachelor’s Degree in science, engineering, or technical field

• Previous experience in facility/area start-up environments

• Previous experience with Manufacturing Execution Systems and electronic batch release.

• Previous experience in formulation and fill/finish.

• Experience with root cause analysis, technical writing / authoring investigations

• Knowledge of lean manufacturing principles

Additional Information:

• 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.The position is for the Lilly Research Triangle Park site and on-site presence is 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.)

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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