Sr. Director - Process Operations Drug Product MSAT

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 unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 145 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is making medicines at a new state‑of‑the‑art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.

The Technical Services / Manufacturing Science (TS/MS) Director is responsible to provide leadership to the TS/MS function for the Lilly RTP site. This includes implementing and overseeing the control strategy aspects of the parenteral, device assembly, and packaging operations. Additional responsibility includes establishing and implementing the organization’s functional agenda in alignment with the business and strategic plan priorities. The TS/MS Director is a member of the RTP Site Lead Team.

• Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence.
• Provide Health, Safety and Environmental (HSE) and Quality leadership for areas of responsibility. Ensure function meets cGMP requirements. This role has direct interaction with Regulatory Agencies during site inspections.
• Support Site Leadership to build a diverse and capable site organization. Talent management, development, and retention within the RTP organization (and beyond).
• Provide site functional leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and technical effectiveness and efficiency.
• Oversee the manufacturing of RTP products process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for RTP in the device assembly, packaging, and syringe filling operations.
• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Lead risk management activities as it pertains to products.
• Support the delivery of equipment and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation.
• Support and/or lead TSMS technical projects to improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the tech agenda.
• Develop, monitor, and appropriately react to established statistically based metrics in real‑time to assess process variability and capability.
• Develop local processes and procedures for the TS/MS function.
• Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
• Ownership of the Site Validation Plan and lead site validation efforts.
• Ownership of the Site Sterility Assurance Plan.
• Drive stability strategy for RTP products.
• Ensure the function is aligned and driven to meet production throughput goals including daily operation, deviation and change management, variability reduction, and equipment/system reliability.
• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Active leadership in the implementation of Lean principles and the site Value Stream Map.
• Partner with Engineering, Quality and Operations leadership meet deliver operational results.
• Participate in the development and implementation of strategies associated with…