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Lilly Sr Director - Technical Services / Manufacturing Science in Concord, 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.

Position Description:

The Technical Services / Manufacturing Science (TS/MS) Sr Director is responsible for providing leadership to the TS/MS function for the Lilly Concord 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 Sr Director is a member of the Concord Site Lead Team.

Key Objectives/Deliverables:

  • Active member of the Concord 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 Concord 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 Concord products including implementation of the process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for Concord in the device assembly, packaging, and parenteral 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 Program

  • Drive stability strategy for Concord 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 Concord capabilities to an increasing global customer base, other Lilly sites and corporate groups.

Requirements (Education, Experience, Training):

  • cGMP manufacturing experience

  • 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

  • Bachelor’s Degree in chemistry, engineering, biology, or similar field

  • Advanced technical degree preferred

Preferred attributes but not required:

  • 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

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 ( LillyRecruitingCompliance@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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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