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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 state-of-the-art manufacturing site from the ground up. Our new Alzey facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Responsibilities:

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

They are 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.

The Sr Director of TS/MS 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 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.
• Ownership of the Site Validation Plan and lead site validation efforts
• Ownership of the Site Sterility Assurance Program
• Drive stability strategy for Alzey 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 Alzey 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:

• Bachelor’s degree in chemistry, engineering, biology, or similar field
• cGMP manufacturing experience
• Technical management or leadership experience including leading a cross functional group
• Fluent in English and German
• 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.

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 ( Lilly_Recruiting_Compliance@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 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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