Senior Director, Engineering - Advanced Therapies

Lilly • Lebanon, IN

3d • $168,000 - $246,400 • Onsite

About The Position

Lilly is constructing a cutting-edge facility in Lebanon, Indiana, for the manufacture of new modalities including Gene Therapy. This facility will be Lilly’s most technically advanced manufacturing site, focused on delivering the next wave 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 team, contributing to both clinical and commercial supply.

The Senior Director of Engineering is responsible for managing the site engineering function, ensuring it has the necessary capacity, capability, and leadership structures to meet site engineering deliverables supporting the manufacturing plan. This role provides administrative and technical leadership for process engineering, process automation, maintenance, utilities, plant and project engineering, and engineering competencies. As a member of the Lilly Lebanon Advanced Therapies Site Lead Team, reporting directly to the Site Head, the individual will share collective responsibility for developing and implementing the site's strategic direction, organizational capability, and management. The Lead Team drives the site towards long-term business objectives, continuously develops the business and organization for the future, and manages cross-functional issues.

During the project delivery and startup phases, the Site Lead Team roles will be dynamic, supporting project delivery, building a new organization, implementing systems and processes for GMP operations, and fostering site culture. This requires significant collaboration, creativity, and resilience as the site scales to full GMP manufacturing capacity through startup.

Requirements

• Minimum of a Bachelor's degree (or equivalent) in a relevant Engineering discipline
• 10+ years of experience in a leadership role managing operations within the pharmaceutical industry, with specific knowledge and understanding of cGMPs and how they apply to manufacturing operations.
• Direct experience in Drug Substance or Drug Product manufacturing.

Nice To Haves

• Strong ability to form effective relationships at all levels.
• Ability to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision-making processes.
• Ability to connect and communicate effectively with all levels of the organization on site.
• Demonstrated track record of successfully developing, managing, and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
• Experience developing and managing extremely talented, engaged, and high-performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
• Experience with manufacturing of advanced therapies (Biotech, Cell and/or Gene Therapy) is preferred.

Responsibilities

• Build the organization with the necessary capability, capacity, and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Define the site engineering priorities & roadmap to develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and incorporating external experiences.
• Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
• Support the project team as the end-user, providing feedback and support on design decisions, commissioning strategies, and startup plans.
• Collaborate to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Develop and adapt organizational structure to provide correct and capable resources and management to deliver the site to a full-scale GMP manufacturing scale.
• Ensure systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities, and facilities.
• Build technical relationships with relevant corporate departments and sponsor strategic corporate initiatives at a site level.
• Continue to define and support the site engineering priorities & roadmap post-startup, integrating the functional agenda with site priorities.
• Ensure the site is in compliance with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
• Maintain an external focus, benchmarking best practices across the network and externally.
• Ensure equipment, processes, utilities, and facilities remain and operate in a qualified and safe state.
• Ensure equipment maintenance and utilities operation are performed and documented to the highest standards of safety and quality.
• Manage the site investment processes for assets (planning, prioritization, resourcing, project management, capital accounting, and reporting).
• Own the development and delivery of the capital investment plan in accordance with site objectives for new products, recapitalization of assets, and facility modernization.
• Ensure a robust control system is established and maintained to manage the business, identify compliance issues, and escalate issues appropriately.
• Develop future management and technical leadership for the site and for potential global assignments.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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: Senior