Senior 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Senior Director of Parenteral Operations is responsible to provide leadership to Parenteral Operations and cross functional leadership for the start-up of new Pre-filled Syringe (PFS) lines at Lilly RTP manufacturing site. The Sr. Director of Parenteral Operations will lead the operational readiness agenda of the new lines through the different project phases, in strong partnership with other Senior Director of Operations.

Responsibilities:

• Provide Operations leadership for new Parenteral lines project and start-up activities. Operations leadership encompasses Health, Safety, Environmental (HSE), Quality, and Operational excellence deliverables. Deliver new PFS lines with effective and timely project delivery, leading with cross-functional integration and direct supervision of operations team.  Project delivery encompass equipment qualification, operational start-up, submission, process validation, and regulatory inspection.
• Support Site Leadership to build a diverse and capable site organization based in engineering first principles and operational excellence.  Talent management, development, and retention within the RTP organization (and beyond).
• Represent operational capabilities beyond the Lilly RTP site (e.g. other Lilly sites and global functional groups).  Partner with Technical Services, Quality and Engineering leadership to deliver operational results.
• Actively engage team and deliver significant capital and technological projects. Deliver equipment, lines, and supporting systems through user requirements, design, build, verification, qualification, validation, and subsequent operation.
• Develop local processes and procedures for the operational function. Ensure practice matches procedure.
• Ensure the functions are aligned and driven to meet project delivery goals and production throughput goals including daily operation of the manufacturing lines, deviation and change management, equipment/system delivery.
• Champion continuous improvement.
• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• This role has direct interaction with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for parenteral formulation and filling.

Basic Requirements:

• Bachelor's Degree in Engineering or a Life Science
• At least 10 years engineering experience at a manufacturing site
• At least 5 years previous management or leadership experience including leading or working effectively with a cross functional group

Additional Skills/Preferences:

• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Ability to handle multiple competing priorities
• Front line experience in parenteral drug product operations
• Solid understanding of basic requirements of regulatory agencies
• Previous facility or area start up experience
• Previous experience in operations and engineering
• Previous experience with highly automated equipment
• Previous experience with drug product formulation and filling in aseptic environment
• Previous equipment qualification and process validation experience