Operations Line Lead - Formulation (Nights)

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.

Operations Line Lead – Formulation

• Organization Overview:
• 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 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 serve an extraordinary purpose. For more than 140 years, we have worked 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 world’s greatest health challenges. We explore how next generation therapeutics, new technologies, and data analytics can improve patient health and the healthcare system. Our team shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts.
• One of the most recent actions Lilly has taken is designing and building a new, modern, and groundbreaking facility in Raleigh-Durham North Carolina! This is an exciting opportunity to help build a facility which will manufacture, assemble, and package parental drug products.

• During the project phase, the Line Lead (Lead Technician) – 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 possibility of international travel based on program need. This role is expected to become a subject matter expert for the formulation and preparation equipment and process and will be directly involved with training future new hires.
• After project phase completion, this role will be responsible for line (suite) leadership, daily operations, development of operators, requalification tasks, ensuring compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan. After project phase completion this role will be exclusively night shift.

• Provide commissioning, qualification, and operational readiness support during project phase.
• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Formulation area.
• Provide frontline leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Technical leader: Key resource for troubleshooting and functions as the primary point of contact for unexpected shop floor events.
• Responsible for coordinating and deploying technical training and ensuring all operators are qualified to perform tasks.
• Assist Supervisor in development and performance evaluations of shift operators.
• Key liaison between operation and support functions.
• Line Lead is a “working leader” by operating the equipment and leading the shift operations to meet production demands.
• Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.)
• Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Line Leads are the back up for the Supervisor.

• High School Diploma or equivalent
• Minimum 6 to 12 months’ relevant experience, (education may be substituted for experience with manager discretion)
• Demonstrated leadership skills with ability to train and mentor peers
• Ability to effectively communicate (written and verbal)
• Flexibility and problem-solving skills
• Basic digital literacy (desktop software) is required.
• Must Pass a “fitness for duty” physical exam
• Must be able to lift 45lbs
• Ability to work 12-hour shifts on nights (2-2-3 schedule) with additional overtime as the need arises
• Project phase will require a baseline 5 day work week with flexibility to adjust hours to support specific project tasks.
• Ability to travel up to 100% during Asset Delivery and < 5% after startup
• 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.

• Scientific/technical degrees or certifications
• Knowledge of current Good Manufacturing Practices (CGMPs)
• Previous experience working in operations/pharmaceutical industry
• Previous experience compounding/formulation in a Grade C environment
• Previous experience using solution filling equipment and/or isolator technology
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Knowledge of lean manufacturing principles

• The position is for the Lilly Research Triangle Park site and during the project phase will require a flexible working schedule which includes working on days or nights as needed.
• Position may require a short duration assignment of 2-6 months in Indianapolis, IN to establish specific process knowledge, establish global contacts, and provide operations support. Additionally, this could include a 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 gown and work in controlled classified areas (aseptic processing)

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 ( Lilly_Recruiting_Compliance@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.

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.

#WeAreLilly