Associate Director Process Engineering - Small Molecule API

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 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’s global purpose is to create medicines that make life better for people around the world. We help people get better, feel better, and live better. It’s been our purpose for more than 140 years. Within our Manufacturing and Quality organization, we strive to hire talented, diverse, and committed people to achieve our mission of delivering reliable supply of these innovative medicines to patients, with safety first and quality always. 

Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. 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 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 – Small Molecule Active Pharmaceutical Ingredients (API) provides leadership and direction to the process engineers to ensure that engineering deliverables are sufficiently resourced and qualified to support the Small Molecule 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 products. Additionally, the Associate Director of Process Engineering - Small Molecule leads this 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 2028+), leadership roles will be fluid and dynamic as we endeavor to support the project delivery teams, build a new organization, develop and implement the necessary 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 full scale API GMP manufacturing through start up. 

Responsibilities:

Pre-Startup and Startup Phase

• Attract, hire, and onboard a significant number of top talent to the Small Molecule Process Engineering team, establishing the right attitude, curiosity, and learning agility to deliver on the site mission.
• 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 business systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experience.
• 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 & qualification strategies etc.
• Collaborate with project team to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Organize and implement strategy for creating engineering standard operating procedures (SOPs) for startup and post startup phases.
• Partner with Process Research and Development (PR&D) leadership to ensure the Operations teams reflect the speed, innovation, flexibility, and reliability needed to meet PR&D and partnering organization