Durham, North Carolina

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.

Organization Overview:

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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up.

Responsibilities:

The Device Assembly and Packaging (DAP) Operations Director is responsible to provide leadership to DAP Operations and cross functional leadership to the DAP Flow Team for the Lilly RTP site. The Operations Director will establish the operational organization and readiness agenda in alignment with the business and strategic plan. The Operations Director will also be a member of the RTP Site Lead Team ensuring safety, quality, and operational excellence.

Key Objectives/Deliverables:

  • Provide Health, Safety and Environmental (HSE) and Quality leadership for the DAP operational and flow team. 

  • 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).

  • Provide operational technical leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency. 

  • 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 production throughput goals including daily operation of the manufacturing lines, deviation and change management, variability reduction, and equipment/system reliability.

  • 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 device assembly, and packaging.

Basic Qualifications:

  • Bachelor's Degree in Engineering

  • At least 10 years of engineering experience at a manufacturing site

  • At least 5 years of previous management or leadership experience including leading or working effectively with a cross functional group

Additional Preferences:

  • Front line experience in device assembly and or packaging operations

  • Excellent interpersonal, written and oral communication skills

  • Strong technical aptitude and ability to train and mentor others

  • Ability to handle multiple competing priorities

  • 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 combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment

  • Previous equipment qualification and process validation experience

  • Previous experience with Manufacturing Execution Systems and electronic batch release.

  • Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs

  • Previous experience with deviation and change management systems including Trackwise

Additional Information:

  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.

  • Position may require travel to Indianapolis to establish specific device knowledge and establish global contacts.

  • Ability to work 8 hour days – Monday through Friday

  • Ability to work overtime as required

  • Ability to travel up to 20% during Asset Delivery and < 10% after startup

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
 

Durham, North Carolina

Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
Our mission 
We make medicines that help people live longer, healthier, more active lives.
Our values
Integrity, excellence, respect for people
Our vision 
We will make a significant contribution to humanity by improving global health in the 21st century.

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