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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

Responsibilities:

The Technical Services / Manufacturing Science (TS/MS) Sr Director is responsible for providing leadership to the TS/MS function for the Lilly Kenosha manufacturing site.  This includes implementing and overseeing the control strategy aspects of the parenteral operations. 

He/she is a member of the Site Lead Team and participates in all SLT responsibilities such as: Strategic and business planning, objectives and priorities setting, control and monitoring of activities, periodic reviews of quality systems, etc.

The TS/MS Sr. Director will establish the TSMS organization and lead the technical agenda (product/process) for the site.

He/she is responsible for ensuring that processes are established in compliance with all applicable standards: HSE, Quality, Human Resources, FRAP/Finances, Ethics (red book), and Lilly values.

Key Objectives/Deliverables:

Active member of the Kenosha 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 Kenosha 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 Kenosha products including implementation of the process control and validation strategy.  The scope of the role includes those commercially manufactured and targeted for Kenosha in the parenteral 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 Kenosha 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 Kenosha capabilities to an increasing global customer base, other Lilly sites and corporate groups.

Ensure audit & inspection readiness. Host audit & inspection. Assure timely closure of all regulatory commitments related to his/her function.

Basic Qualifications/ Requirements:

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

10+ years cGMP manufacturing experience

Technical management or leadership experience including leading 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 Skills/Preferences:

Demonstrated regulatory inspection experience

Experience working with parenteral manufacturing

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

Additional Information:

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 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.

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