Lilly
Sr Director - TSMS
Lilly, Pleasant Prairie, Wisconsin, United States, 53158
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.
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 to 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.
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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 to 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.
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