Associate 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.

Responsibilities:

The Technical Services/Manufacturing Science (TSMS) Associate Director is responsible for the staffing, training, and leadership of the TSMS group. The TSMS group provides technical leadership for PAR (formulation, filling, visual inspection) or DAP (device assembly, packaging) operations for commercially manufactured products targeted for transfer to the Alzey site. The Associate Director will be responsible for supporting the day-to-day TSMS activities as well as planning for the 3-6-month horizon.  The TSMS Associate Director is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing products in area of influence (PAR or DAP) including the interaction of the chemistry, equipment, components, aseptic processes, and container closure systems.
• Support Site Leadership to build a diverse and capable TSMS organization, with a focus on supporting the areas of device assembly and packaging.
• Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development.
• Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency.
• Determine staffing and resource needs to support site TSMS requirements.
• Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Provide technical guidance to the TSMS group.
• 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).
• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for the various operational areas.
• Manage external contracts/resources and project management resources, as needed.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
• Drive control, capability, productivity, and continuous improvement for the process.
• Support and/or lead TSMS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
• Serve as technical interface external to the Alzey site.
• Work within or lead multi-functional teams in positive fashion to implement TSMS objectives and deliver on business plan and quality objectives.
• Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

Basic Qualifications:

• BS, MS, or Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Minimum 1 year of management or leadership experience, including leading or working effectively with a multi-functional group
• Minimum 5 years of regulated industry experience

Why work for Lilly?

Pioneering Spiri t: 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 “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.

Additional Skills/Preferences:

• Strong technical aptitude and ability to train and mentor others
• Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Solid understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
• Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.)
• Previous experience with combination products, device assembly, pharmaceutical packaging
• Previous facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous experience with highly automated equipment
• Previous experience with deviation and change management systems including Trackwise

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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