Associate Director - TS​/MS - Lebanon API

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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.

The Associate Director – Technical Services/Manufacturing Science (TSMS) is responsible for managing the activities of TSMS personnel. The Associate Director TSMS must balance coaching a technical staff, prioritization and staffing for organizational build to support production activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.

The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), leadership 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.

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Complete formal Performance Management and development of staff. Provide coaching and direction to team members.
• Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity.
• Ensure adequate oversight and technical excellence for investigations and complaints.
• Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality.
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.

• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of operational excellence
• Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and practices where…