Director - QC Advanced Therapies LP2 Quality

Eli Lilly and Company • Lebanon, IN

2d • Onsite

About The Position

Lilly is constructing a cutting-edge facility (LP2) in Lebanon, Indiana, for the manufacture of new modalities, including Gene Therapy. This facility will be Lilly’s most technically advanced manufacturing site, focusing on the delivery of innovative products. It will incorporate next-generation manufacturing technologies and advanced data collection and analysis platforms to enhance safety, quality, and process performance. This is a unique opportunity to be part of a greenfield manufacturing site startup, where the successful candidate will contribute to the design, commissioning, and startup of the facility for both clinical and commercial supply. The Quality Control Laboratory is responsible for ensuring patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Requirements

• Bachelor's degree in a science field related to chemistry, microbiology, biology, or other science discipline.
• 5+ years of cGMP commercial manufacturing experience in QC or associated disciplines such as Manufacturing, TS/MS, Quality Assurance, or Engineering.
• 3+ years of experience leading teams.
• 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.

Nice To Haves

• Experience with large molecule and/or viral vector testing techniques.
• Experience with management of laboratories or start-up of new laboratories.
• 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.
• Flexibility, agility, and right-sizing laboratory processes within the scope of global laboratory harmonization will be a key factor for success in this role.

Responsibilities

• Proactively manage day-to-day laboratory business, including interaction with GFD and construction teams, as well as internal teams for laboratory start-up and execution of testing.
• Proactively manage day-to-day personnel, including interaction with production planners, sample submitters, analysts, and other cross-functional groups to maintain laboratory workload and throughput.
• Maintain a high-level understanding of laboratory processes and provide site leadership with information about laboratory capacity, capability, and forward planning for current molecules and new product introduction.
• Develop career plans for laboratory SMEs, project managers, 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.
• Provide strategic oversight for LIMS usage, implementation, and deployment.
• 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 the 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 ensure customer needs are met.
• Help define and execute inspection readiness activities in the QC laboratories.
• Oversight of laboratory testing performed by external partners for products manufactured by LP2 or by third-party manufacturers.
• Ensure the laboratory is capable of receipt, testing, and release of incoming materials, in-process, release, and stability gene therapy samples for gene therapy products manufactured at LP2 or by external partners.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director