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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.

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 making medicines at a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.

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.

+ Oversee the manufacturing of RTP products 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

+ 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 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 10 years cGMP parenteral 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

+ 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

Education Requirements:

+ Bachelors Degree in chemistry, engineering, or biology

Other Information:

+ The position is for the Lilly Research Triangle Park site.

+ Ability to work 8 hour days – Monday through Friday

+ Ability to work overtime as required

+ Limited travel < 5%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$163,500 - $239,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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