Operations Supervisor (Indy RLT)

Operations Supervisor Indy RLT

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our worlds greatest health challenges.

Responsibilities :

Operations Supervisor Indy RLT is responsible for shift leadership of manufacturing employees. They will lead the production of drug products following strict cGMP guidelines and are subject matter experts to resolve all production-related and quality events in a timely manner. This individual will coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug products and radioisotopes. They must ensure that the manufacturing lines are adequately staffed with trained / qualified employees. Strict adherence to safety while working with radioactive materials following ALARA principles and NRC guidelines as required. This is a direct line supervision of operators on a 12-hour shift.

Key Objectives :

• Be a subject matter expert to resolve all manufacturing issues on the shift, or escalate when necessary.
• Manual and / or automated production of aseptic radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records.
• Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
• Lead investigation, resolution, and mitigation of deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the Lilly Indy RLT facility.
• Monitor of the production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
• Lead continuous process improvement initiatives of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).
• Organizing and scheduling of manufacturing activities, production technicians and manufacturing specialists in accordance with the weekly production plan.
• Lead investigations for quality events during routine manufacturing.
• Oversee implementation of corrective and preventative actions, and performing CAPA effectiveness checks for GMP manufacturing activities.
• Track and trend batch data and ensuring manufacturing and related quality KPIs are met.
• Ensure production staff consistently adhere to all health and safety, and radiation safety guidelines, policies, and SOPs.
• Provide training and guidance to production staff.
• Ensure the production team operates in accordance with cGMPs to produce drug product within specification.
• Serve in a direct production role as needed.
• Aid in qualifying equipment and clean room for production use.
• Participate in Process Team activities when needed.

Basic Requirements :

Additional Skills / Preferences :

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.

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), and 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 $35.33 - $51.83. 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.