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Director – Technical Services / Manufacturing Science

Durham, North Carolina

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Req ID R-10450 Title Director – Technical Services / Manufacturing Science City Durham State / Province North Carolina Country United States

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.

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 140 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.

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.   

Key Objectives/Deliverables:

  • 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. 
  • The start-up and compliant manufacturing of RTP products including implementation of the 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
  • Lead technical operational readiness from a control strategy perspective transitioning from project to running mode.  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 ensure a successful start-up, 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 the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
  • Represent RTP capabilities to an increasing global customer base, other Lilly sites and corporate groups.
  • Continuous improvement champion

Minimum Requirements:

  • At least 7 years cGMP manufacturing experience
  • At least 5 years technical management or leadership experience including leading or working effectively with a cross functional group
  • Excellent interpersonal, written and oral communication skills
  • Strong technical aptitude and ability to train and mentor others
  • Ability to handle multiple competing priorities

Additional Preferences:

  • Demonstrated regulatory inspection experience
  • Experience working with parenteral manufacturing
  • Previous facility or area start up experience
  • 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 deviation and change management systems including Trackwise

Education Requirements:

  • Bachelors Degree in chemistry, engineering, biology, or similar field
  • Advanced technical degree preferred

Other 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.
  • 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-10450.

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.

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