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 (LP2) 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 Associate Director (AD) is the laboratory leader role in the LP2 Quality Control Laboratory providing direction for the start-up project phase as well as the operational areas of the laboratory. This involves the design and execution for the area's daily workload planning and compliance. The AD will serve as a liaison between the site leadership and global laboratory leadership to ensure timely start-up and laboratory testing delivery. The AD must be approachable and committed to personnel interactions, as they will spend considerable time as a mentor and supporter of reporting staff. This role also includes the oversight of laboratory testing performed by external partners, for products manufactured by LP2 or by third party manufacturers. The AD will 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. Due to the dynamic nature of gene therapy modalities, flexibility, agility, and right-sizing laboratory processes within the scope of global laboratory harmonization will be a key factor for success in this role.

Key Objectives/Deliverables:

Proactively manage day-to-day laboratory business. This includes 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. 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 providing site leadership 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. LIMS usage, implementation, and deployment support by providing strategic oversight. 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:

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. 2+ years of direct gene therapy experience. 3+ years of experience leading teams

Additional Preferences:

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. 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Our current groups include:

Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $198,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. 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Associate Director/Director - Quality Control, Gene Therapies