Principal Scientist – TSMS Device Assembly

Eli Lilly and Company • Pleasant Prairie, WI

3d • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Device Assembly Technical Services / Manufacturing Science (TSMS) Principal Scientist is a technical position that develops and implements a technical agenda and provides technical leadership for device assembly activities at the Lilly Kenosha County (LKC) site. As LKC is a greenfield site, this role will be foundational in standing up the device assembly technical program — from equipment and process design input, through tech transfer and process validation (PV) readiness ahead of the site's PV ramp, to sustaining commercial support. Primary objectives include building the technical foundation for, and ultimately delivering, compliant start-up and manufacturing of LKC device assembly operations, including development and implementation of the process control and validation strategy. The scope of the role is device assembly for products transferred to and/or launched at the LKC site. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the site expert in the regulatory, internal, and other requirements governing device assembly. A key part of this role is ensuring consistency in approach and process across the product lifecycle — from tech transfer through regulatory submission and into routine manufacturing — and in aligning LKC's technical approach with sister DAP sites as the network matures.

Requirements

• BS or MS in engineering, or other related scientific discipline.
• Minimum of 5 years directly supporting pharmaceutical or medical device manufacturing (or other related experience).
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills, with the ability to operate with a high degree of autonomy in a start-up environment.
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Knowledge of aspects of drug product, device, and combination product manufacturing.
• Experience supporting cGMP manufacturing operations.
• Experience in TSMS, MSAT, or Operations, particularly in device assembly.
• Technical transfer experience, including equipment qualification and process validation.
• Experience supporting or standing up a new site, line, or greenfield facility.
• Demonstrated successful leadership of cross-functional teams.
• Previous experience with deviation and change management systems.
• Project Management certification.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products and device assembly, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Serve as a technical SME during the design, build, and commissioning phases at a greenfield site, providing manufacturing science input into device assembly equipment, facility, and process design to support future tech transfer and validation.
• Provide technical support for all device assembly start-up activities (e.g., tech transfer, equipment/process qualification, process validation) ahead of and through Process Validation.
• Provide technical support for non-routine investigations (e.g., deviations, complaints) related to device assembly, including consultation on quality and stability.
• Prepare, review, approve, and provide technical support for relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, and Process Monitoring.
• Ensure an accurate instruction set (tickets & procedures) describes the device assembly process as performed and the control strategy for discrete manufacturing steps.
• Own the technical agenda for an assigned device assembly product, platform, or validation process.
• Lead risk management activities pertaining to assigned device assembly products and processes.
• Develop, monitor, and appropriately react to statistically based metrics in real time to assess device assembly process variability and capability.
• Support and/or lead TSMS technical projects to ensure a successful device assembly start-up and improve process control, yield, product quality, and/or productivity; implement process changes and improvements through the technical agenda.
• Contribute to the stability strategy for LKC products.
• Serve as a technical interface with upstream suppliers, equipment vendors, and the global device assembly network, including sister-site DAP teams, to drive technical consistency across the network.
• Serve as a technical mentor for TSMS engineers, scientists, and other disciplines.
• Provide audit and regulatory inspection (including PAI) support, as needed.
• Work within and lead cross-functional teams in a positive manner to implement TSMS objectives and deliver on business plan and quality objectives.
• Ensure a safe working environment through compliance with safety rules and by actively participating in safety-related activities, helping to establish a strong safety culture from site start-up.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Associate degree