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.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:

The Sr. Manager is a team management role in the Quality Control Laboratory helping to provide direction and/or conduct the area’s daily workload planning and compliance. The Sr. Manager will serve as a liaison between higher Laboratory management and analysts ensuring timely communication and laboratory testing delivery. The Sr. Manager must be approachable and committed to personnel interactions, as they will spend considerable time as a mentor and supporter of reporting staff. The Sr. Manager is also responsible for coordinating laboratory and environmental monitoring analysts’ performance management. The Sr. Manager will ensure the laboratory is capable of receipt, testing, and release of incoming materials, in-process, release, and stability gene therapy samples.

Key Objectives/Deliverables:

• Proactively manage day-to-day laboratory business. This includes interaction with production planners, sample submitters, analysts, and other cross-functional groups to maintain laboratory workload and throughput.

• Maintain a high-level understanding of the laboratory processes and be responsible for management of analyst and technician training on laboratory and sampling methods.

• Develop career plans for laboratory analysts and technicians.

• Monitor and assure compliance to all procedures, methods, and other regulatory commitments.

• Provide technical understanding of the regulations applicable to laboratory testing and sampling for cGMP purposes.

• Participate in internal audits and external inspections.

• Review of laboratory analyses, both analytical and microbiological.

• LIMS usage, implementation, and deployment support by providing method-specific guidance.

• Utilize technical skills to support investigations into out of spec results and aberrant data.

• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.

• Contribute to development and implementation of Global Lab Quality Standards.

• Comply with and implement safety standards.

• Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

• Interact effectively with internal business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.

• Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met.

• Help define and execute inspection readiness activities in the QC laboratories.

Minimum Requirements:

• Bachelors (4-year) degree in a science field related to chemistry, microbiology, biology, or other science discipline.

Additional Preferences:

• 2+ years of demonstrated relevant experience in a GMP Testing Laboratory.

• 1+ years of experience in laboratory or people management.

• Strong oral and written communication skills and demonstrated through documentation and presentation skills.

• Experience with large molecule and/or viral vector testing techniques.

• Experience with management of laboratory supplies and reagents.

• Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.

• Demonstrated strong interpersonal interaction skills.

• Ability to focus on continuous improvement.

• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

• Deep understanding of compliance requirements and regulatory expectations.

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.

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.

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