Associate Director - Clinical Trial Device Assembly Lead (DDCS)

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.

In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The DDCS organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users’ needs and intended uses.

The Delivery Device and Connected Systems (DDCS) group is looking for a candidate who can facilitate the implementation of a Clinical Trial (CT) autoinjector device assembly line. This will require qualification of the line and creating the infrastructure (including GMP operators of the line) to run the line and produce GMP combination products suitable for human use. In addition, this role will support the delivery of a line to product multi-fixed dose devices for CT use and CT readiness for large volume injection (LVI) CT needs. This role will also include oversight and people leadership responsibility for the machine shop.

The role requires technical expertise, project management, communication skills and strategic planning and implementation as theses CT device capability do not exist today. In addition, this role will be responsible for strategic collaborations with select CMOs.

Position Responsibilities:

Pre-Startup and Startup Phase:

• Lead and/or supervise the pilot plant & machine shop team/contractors.
• Develop the strategy and roadmap to establish the necessary capability and capacity for Dev and CT device manufacturing.
• Plan and manage business operational expense, capital and headcount targets.
• Operation excellence – “right to operate” to conform to the highest standards of safety, quality, and operational excellence. Establish lean practices and a continuous improvement mindset throughout operations
• Qualify and commission the device assembly lines to ensure fit for use. Develop and implement the appropriate control strategy for the device assembly pilot plant.
• Develop and implement the systems and processes needed to run the site and interact with key stakeholders.

Post Startup routine manufacturing operations:

• Develop the strategic and operational plans and schedules for device production operations and be responsible for the execution of these plans in his/her areas of direct responsibility.
• Ensure pilot plant operations remain compliant with all applicable regulatory requirements. (e.g. Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
• Deliver the CT devices and development samples to enable device innovation, development, and meet clinical trial needs on time.
• Review site performance periodically with respect to these plans and take corrective actions as appropriate.

Other responsibilities:

• Serve as the primary interface for CT device assembly with all functional groups inside and outside of the DDCS group, other functions supporting devices, Lilly drug development functional groups, external development organizations, and manufacturing.
• Serve as the primary contact for strategic collaborations with select CMOs.
• Collaborate with IDM Asset Delivery on best practices and recommended approaches for C&Q activities

Minimum Requirements:

• Bachelor's degree in engineering or related field
• 10 years of product development experience including drug delivery, medical device, or pharmaceutical industry experience.
• Working knowledge of cGMP’s, especially proficiency with process & equipment commissioning & qualification practices.
• Knowledge of device manufacturing processes, equipment, and manufacturing operations.
• People leadership and influencing skills.

Additional Skills/Preferences:

• Must be able to coordinate the roles of multiple other groups and individuals, internal and external.
• Strategic thinking: Assess the balance between technical risk, business impact, financial analysis, and customer preferences.

Other Information:

• Travel: 15-25%
• Role is located in Indianapolis, IN: LTC-N

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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