Senior Director TSMS

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 is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Alzey, Germany. This is an exciting opportunity to help build and operate a brand-new inclusive manufacturing site from the ground up. Our new Alzey facility will be one of Lilly’s most technically sophisticated manufacturing sites and will include next-generation manufacturing technologies and sophisticated data collection and analysis platforms that will result in safety and quality improvements, and variability reduction.

Responsibilities:

The Technical Services / Manufacturing Science (TS/MS) Sr Director will provide collaborative leadership to the TS/MS function for the Lilly Alzey site. This includes implementing and supporting the control strategy aspects of the parenteral, device assembly, and packaging operations.

They are members of the Lead Team and collaborate in all SLT responsibilities, such as Strategic and business planning, setting objectives and priorities, controlling and monitoring activities, and periodic reviews of quality systems.

Key Objectives:

• Active member of the Alzey 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 Alzey 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 Alzey products including implementation of the process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for Alzey 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.
• Ensure the function is aligned and driven to meet production throughput goals including daily operation, deviation, 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
• Represent Alzey capabilities to an increasing global customer base, other Lilly sites and corporate groups.
• Ensure audit & inspection readiness. Host audit & inspection. Assure closure of all regulatory commitments related to their function.

Basic Qualifications:

• Bachelor’s degree in chemistry, engineering, biology, or similar field
• cGMP manufacturing experience
• Technical management or leadership experience including leading a cross-departmental group
• On-site presence required

Additional Skills/Preferences:

• Demonstrated regulatory inspection experience
• Excellent interpersonal, written and oral communication skills
• Ability to handle multiple competing priorities
• Experience working with parenteral manufacturing
• Strong technical aptitude and ability to train and mentor others
• 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

Why work for Lilly?

Pioneering Spirit: Become part of a growing team of specialized professionals in Alzey that will grow to up to 1,000 colleagues over the next three years.

Innovation: You will work in a high-tech production facility that will be equipped with the most advanced technology.

Individual Contribution: Right from the start, you will have the freedom to contribute your ideas and implement them in cross-functional teams.

Career & Development: We attach great importance to supporting our employees individually in their career development and guarantee fair access to professional training worldwide via our “Corporate Lilly University”.

Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension scheme and other individual benefits.

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 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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