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Organization Overview:
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Reports to the Lilly Lebanon Plant 1 Site Head
Main Purpose and Objectives of Position:
The Senior Director Operations – Small Molecule Expansion is directly responsible for managing the manufacturing operations function and ensuring it has the necessary capacity, capability and leadership structures in place to deliver the site manufacturing plan. The role is also responsible for leading the integration of the cross-functional management team that provides functional support to manufacturing operations. This role will be key to ensuring a strong safety culture and establishing a safety focused mindset within the organization. The role will have responsibility for the second increment (expansion) of small molecule manufacturing.
The Senior Director Operations – SM Expansion is also a member of the Lilly Lebanon Plant 1 Site Lead Team, that 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 (startup expected 2026 to 2028), 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.
Responsibilities:
Pre-Startup and 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.
Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning
Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
Support the project team to deliver the facility to you as the end user, by providing feedback and support on design decisions, commissioning strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.
Post Startup:
Develop the strategic and operational plans for Production Operations and be responsible for the execution of these plans in his/her areas of direct responsibility.
Participate in development and delivery of the medium and long term strategic direction for the site.
Ensure Manufacturing Operations remain compliant with all applicable regulatory requirements. (e.g. Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
Ensure the Production Flow Team and Process Teams meet expectations described in Lillys Manufacturing Standards for Operational Excellence
Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
Through leadership of the cross functional management support team, be responsible for implementation of new product introductions & continuous improvement opportunities.
Develop the future management and technical leadership for the site and for potential global assignments.
Basic Requirements:
Minimum of a Bachelor's degree (or equivalent) in a science or engineering field
10+ years of experience in a leadership role within the pharmaceutical industry
Additional Skills/Preferences
Experience in API manufacturing including a Process Safety Management program.
Must possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.
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.
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