Lilly Operations Supervisor - Formulation (Night Shift) in Durham, North Carolina
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.
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.
During the project phase, the Operations Supervisor – Parenteral Formulation will support commissioning/qualification activities required to bring formulation suites 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 formulation process. This role will have the opportunity to be directly involved with hiring and training their team.
After project phase completion, the Operations Supervisor is responsible for shift leadership for multiple drug product formulations 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).
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 3 formulation 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)
High School Diploma or equivalent.
Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.
Previous leadership experience.
Bachelor’s Degree in science, engineering, or technical field
Previous experience in facility/area start-up environments
Skills in providing/receiving feedback and creating employee development plans.
Basic computer skills (desktop software)
Solid understanding of FDA guidelines and GMP 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.
Previous experience with Manufacturing Execution Systems and electronic batch release.
Experience with root cause analysis, technical writing / authoring investigations
Knowledge of lean manufacturing principles
Role requires the ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
Ability to work 12 hour night 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.
Project phase will require a baseline 5 day work week with flexibility to adjust hours to support specific project tasks.
Ability to travel up on 1-3 week assignments for process training and development.
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.
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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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