Overview:Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy 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, 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 start up the facility for both clinical and commercial supply.
The Senior Director of Engineering is directly responsible for managing the site engineering function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the site engineering deliverables in support of the manufacturing plan. They provide administrative and technical leadership for the site engineering function including process engineering, process automation, maintenance, utilities, plant and project engineering, and engineering competencies.
They are a member of the Lilly Lebanon Advanced Therapies Site Lead Team and report directly to the Site Head. The Lead Team has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate/external context.
In the project delivery phase and startup phase of the project, the Site Lead Team roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
Startup Phase:- Be a collaborative, inclusive, energetic leader and support the broader lead team to:
- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
- Defines the site engineering priorities & roadmap in order to develop and implement the systems and processes needed to run the site. This includes leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.
- Serve as a key member of the site HSE Lead Team, ensuring safety focus throughout project delivery and startup.
- Support the project team to deliver the facility as the end user. Providing feedback and support on design decisions, commissioning strategies, startup plan, etc. 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 the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities
- Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a site level.
Post Startup:- Continue to define and support the site engineering priorities & roadmap; integrate 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.
- Have external focus, benchmark best practices across network and externally
- Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state; Ensure that 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 the site objectives for new products, recapitalization of assets, and facility modernization.
- Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
- Develop the future management and technical leadership for the site and for potential global assignments.
Minimum 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.
Preferences:- Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.
- Should have a 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.
- Should have 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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$168,000 - $246,400
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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