Associate Director Process Engineering

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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. 

Position Description:

The Associate Director Process Engineering provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Small Molecule or Peptide production and business agenda.  This role is responsible for the productivity and development of process engineers with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacturing of small molecule or peptide products.  Additionally, the Small Molecule Process Engineering Team Leader leads the Process Engineering organization and influences across functional disciplines to support the Process Engineering agenda, business plan priorities, and compliance plan 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. 

Key Responsibilities: 

• Responsible for supervising and coaching Process Engineering staff for their respective area (peptide support), including completing performance reviews and development planning.
• Oversight of Process Engineering staffing including recruitment, resource planning, and succession planning.
• Provide Process Engineering work coordination and provide Process Engineering input to key functional groups and partners.
• In coordination with engineering function, set and reinforce standards for engineering work product and utilization of first principles.  Partner within Engineering and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Identify, track, and report key indicators of functional performance.
• Have oversight of engineering related technical issues and improvement initiatives.  Review and approve engineering related deviations and change controls. 
• Participate appropriately in site planning processes (capital and resource), representing the interests of the team but with a view to the overall site picture.
• 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.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

Specifically during the startup phase of the Lebanon API site (2025 to 2027) leadership will be expected to be collaborative, inclusive, and support the broader team to: 

• 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 necessary, but also incorporating external experiences and learning  
• Ensure regulatory compliance and operational excellence by supporting lean principles in their respective area
• Support the project team as they deliver the facility to the site team, by providing feedback and support.   

Basic Requirements:

• Bachelor’s degree in Engineering (Chemical or Mechanical Engineering preferred)
• 3+ years experience in engineering role supporting manufacturing, preferably in API manufacturing
• Leadership experience preferred

Additional Preferences:

• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to instill teamwork within the department and demonstrate key interpersonal skills.  
• Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas.  

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