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Organization Overview:

Eli Lilly and Company is breaking ground on a new facility in Lebanon, Indiana, with primary focus on the manufacture of Advanced Therapeutic Medicinal Products (ATMPs) such as gene therapies. The Associate Director, Quality Control, will initially serve as the Quality Laboratory Project Lead responsible for start-up of the Quality Control Laboratories at Lilly's new gene therapy site (LP2). This role is responsible for leading the detailed lab design working in partnership with the Global Facilities Delivery (GFD) and Global Quality Laboratory (GQL) organizations. As the project progresses, this role will transition to site-based laboratory leadership supporting readiness activities including organizational design, staffing, procedures, and processes necessary to provide GMP laboratory testing in support of development, clinical trial, and manufacturing operations.

Responsibilities:

The Associate Director, Quality Control, will lead the start-up and routine operation of the Quality Control Laboratories at Lilly's new Lebanon, Indiana gene therapy pharmaceutical site. The gene therapy site will provide support for development, clinical trial, and manufacturing operations and could continue to expand into additional advanced therapies such as cell therapy. Responsibilities include technical and administrative leadership, as well as, project management.

• Act as GMP Lab Design Leader, working with Global Facility Delivery, global Quality Control Laboratories, Lilly project staff, and selected A&E firms to complete the detailed design of the lab areas including the purchase and qualification of all laboratory analytical instrumentation and equipment employing Quality by Design and Lean Lab principals

• Serve as technical resource to review and approve technical documents

• Work with the Lab Robotics and Lab IT areas for integrating future technology and systems into the delivery plan for startup or future use

• Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the site laboratory operations for the chemical, microbial, and virology labs, including the environmental monitoring program

• Support initial recruiting, build capability, for a diverse leadership and lab staff to support the qualification and startup of the Lab operation

• Maintain overall responsibility for establishing a QC Lab Operation

• Ensure all aspects of safety are incorporated into the design and maintain a safe work environment, including supporting all HSE Corporate and Site Goals

• Establish a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including establishing lab practices, procedures, test methods, etc.

• Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives

• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation

• Ensure set up of all lab materials, chemicals, supplies, and services to support lab operation

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

• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

• Network with other areas to understand best practices, share knowledge, participate in tactical and strategic business planning, and ensure customer needs are met

• Set QC Lab human resource and business plan goals

• Define and execute inspection readiness activities

• Interact with regulatory agencies during inspections regarding cGMP issues

• Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability

• Ensure data integrity by design

Basic Requirements:

• Bachelor of Science in Chemistry/Biology/Microbiology or related science

• Previous pharmaceutical leadership experience including leading or working effectively with a cross functional group

• 5+ years GMP lab experience including analytical testing and method transfer

Additional Preferences:

• Deep understanding of compliance requirements and regulatory expectations

• Previous experience in cell or gene therapy support preferred

• Excellent written and oral communication skills

• Previous LEAN experience

• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.

• Strong technical aptitude and ability to train and mentor others

• Project management experience

• Demonstrated problem-solving and decision-making capability

• Demonstrated technical writing skills

• Proven cross-functional leadership

Additional Information:

• Ability to work 8-hour days – Monday through Friday, onsite

• Ability to work overtime as required

• Available off shift to respond to operational issues

• Ability to travel 10-25% of the time during the project phase to support the design and staffing of the facility

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