Sr Director - Parenteral Operations

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.

Sr. Director, Parenteral Operations

The Parenteral Operations Sr. Director is responsible for providing leadership to the cross-functional Process Teams and Flow Teams supporting the parenteral production areas.  Utilizing the various teams and functions as described in the Manufacturing Standards for Operational Excellence (MSOEs) to ensure that all people, processes, facilities, and equipment are capable and compliant with the requirements of GMPs, OSHA, and any process and practice designated by the company site or plant as necessary in executing or supporting the making of medicine for our patients. The Parenteral Operations Sr. Director will be reporting to the Site Head and is a member of the Kenosha Site Lead Team

Key Objectives/Deliverables:

• Active member of the Kenosha Site Lead Team ensuring safety, quality, and operational excellence.

• Participate in the development and implementation of site strategic and business plans

• Lead the Parenteral Flow Team, in accordance with the Manufacturing Standards for Operational Excellence
• Provide leadership and development to direct reports and members of the Flow Lead Team and be a resource to mentor and coach others as circumstances require.
• Meet performance objectives established for the area of responsibility.
• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Make medicine safely.
• Make medicine within all quality and compliance guidelines that pharma operations are subject to.
• Ensure that the area is capable in respect to key corporate best practices including, but not limited to OSSCE, CAPA, and Lean.
• Support site commercialization and new molecule pipeline plan.
• Understand and participate in the design of the manufacturing control strategy for formulation, filling, visual inspection
• Understand process variability.
• Achieve and maintain a state of control for resources and processes used in the making of medicine.
• Ensure that occasions when resources or processes are not capable, compliant, or in control are identified, investigated, and corrected.
• Where possible and consistent with business needs and objectives, take action to reduce variability and continuously improve performance within the area of responsibility.

• Partner with the Operational Excellence/Continuous Improvement organization in the delivery of MSOE training / education programs and drive Operational Excellence in day-to-day management of the operation.

• Lead and / or facilitate the implementation of projects and initiatives as identified and sanctioned by the site.
• Work with external parties such as Regulatory Agencies during site inspections, other Lilly Parenteral Network Sites, etc.
• Utilizing OSSCE, meet patents and other customer supply demands.
• Make the workplace more productive by taking advantage of diversity, inclusion, and engagement.

Requirements (Education, Experience, Training):

• Bachelor's Degree in Engineering, a Life Science, or Business/Operations
• At least 10 years of experience at a pharmaceutical manufacturing site
• At least 5 years previous management or leadership experience including leading or working effectively with a cross-functional group.
• Previous demonstration of strong leadership skills.
• Strong interpersonal and communication skills.
• Previous experience in supervision of cross-functional team within a Parenteral production environment.
• Solid understanding of quality and corporate policies.
• Solid understanding of the importance of and basic requirements of Regulatory agencies such as the FDA, EMEA, OSHA, and EPA.
• Demonstrated solid judgment and initiative.
• Enthusiastic, positive attitude, flexible, and with a growth mindset
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Other Information:

• Required ability to support personnel working in the aseptic block.
• Required