Supervisor - QC

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Note: This role will be based in Lebanon IN upon construction of the site. Prior to construction, this role will primarily be based with the project team in Indianapolis.

Position Title: Supervisor - QC

Position Type: Full Time

Job Level: B5

Location: LP1

Job Function: Quality Control

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Description:

The Supervisor – QC is directly responsible for managing the quality control laboratory for their respective area and shift. The Supervisor - QC is responsible for the day-to-day management of laboratory activity in the assigned area in order to meet all health, safety, environmental, and quality standards. The Supervisor – QC provides direction for lab workload planning and scheduling, supervise lab technicians, ensure laboratory work is performed according to cGMPs, and provide overall customer service to API manufacturing.

In the project delivery and startup phase of the project (startup expected 2025 to 2027), the QC Supervisor role will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

Key Objectives/Deliverables:

• Build and promote a strong Safety and Quality culture. Maintain a safe working environment and conduct operations activities in a manner that protects safety, environment and quality
• Prioritize sampling/testing based on manufacturing schedules.
• Understand API manufacturing processes, scheduling processes, chemical sampling processes, and laboratory processes to proactively identify problems or gaps, develop action plans and resources, and to provide timely and appropriate resolution.
• Understanding of laboratory methods and material specifications.
• Ensure compliance with SOPs.
• Ensure audit action items assigned to responsible teams are completed in a timely manner.
• Manage events as required, ensuring appropriate communication within the team and with external teams. Provide input on investigations.
• Responsible for alignment of Performance Management objectives with department, site and corporate strategies for direct reports.
• Responsible for the coaching, mentoring and development of staff.
• Participate in the merit delivery and promotion process.

Basic Requirements:

• Associates degree or equivalent in a related science or 4-6 years of experience within a cGMP laboratory environment.
• Working knowledge of cGMP regulations for QC laboratory applications.
• Excellent teamwork and communication skills.
• Strong attention to detail.

Additional Preferences:

• Previous supervisory experience preferred.
• Demonstrated strong problem solving and analytical troubleshooting skills.
• Ability to prioritize work to meet customer needs and demonstrate flexibility.
• Excellent interpersonal skills and networking skills.
• Strong computer skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong written and verbal communication skills.
• Solid understanding of FDA guidance and cGMP requirements.

Other Information:

• Must complete applicable learning plan.
• Role may require working 12-hour rotating shifts, once site is operational.
• Overtime as required as needed to meet the business needs.
• Tasks require entering laboratory and manufacturing areas which require wearing appropriate PPE.
• Task may require working in areas containing allergens and other potentially hazardous materials.
• Minimal travel may be required.

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