Sr. Manager - QC Labs

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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 Sr. Manager - QC Labs leads the day-to-day activities of the assigned QC staff. Plans work for the group to respond to changing priorities. Maintains a safe, orderly, and compliant work area according to company safety standards and cGMP regulations. Position requires 0-3 years of supervisory experience and 2-5 years of solid technical skills related to applied area. Assists with workload, as needed.

In the project delivery and startup phase of the project (startup expected 2025 to 2027), the Sr. Manager - QC Labs 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

• Manage the day-to-day activities of the assigned laboratory group.
• Assign and monitor laboratory workload of routine and non-routine analyses by appropriate chemical, biochemical, and microbiological test methods. Performs assays as needed.
• Plan and organize analytical projects required to achieve group and corporate objectives.
• Evaluate, coach, and manage personnel performance. Set group objectives with mgt.
• Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
• Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
• Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
• Be a technical resource for QC.
• Serve as a technical expert on the methods performed in the group and the results obtained.
• Use scientific expertise to aid coworkers for troubleshooting, laboratory investigations and problem resolution. Implement process improvements with management.
• Assure adherence of acceptable cGMP practices by staff during execution of all work tasks.
• Compile and analyze data, prepare graphs, and write SOPs/reports. Conduct document reviews.
• Review test results for conformance with specifications and effective documents.
• Evaluate data to detect product or method-related trends. Write periodic trend summaries.
  
  
  

Basic Requirements

• Bachelor’s degree in relevant field (prefer Science or Engineering)
• Previous experience working in a GLP/GMP laboratory or regulated environment
  
  
  

Additional Preferences

• Demonstrated strong problem solving and analytical troubleshooting skills.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Strong computer skills
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong written and verbal communication skills.
• Excellent teamwork and communication skills. Attentive to detail.
• Previous leadership experience.
• Ability to take initiative, to be assertive, to lead by example and to build relationships.
• Working knowledge of cGMP regulations for QC laboratory applications is required.
  
  
  

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