Principal Scientist – TSMS Device Assembly

Lilly • Pleasant Prairie, WI

5d • $67,500 - $173,800 • 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.

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 and visas for this role.

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

• Develops and implements a technical agenda and provides technical leadership for device assembly activities at the Lilly Kenosha County (LKC) site.
• Builds the technical foundation for, and ultimately delivers, compliant start-up and manufacturing of LKC device assembly operations, including development and implementation of the process control and validation strategy.
• Ensures 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.
• Understands the scientific principles required for manufacturing parenteral drug products and device assembly, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Serves 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.
• Provides technical support for all device assembly start-up activities (e.g., tech transfer, equipment/process qualification, process validation) ahead of and through Process Validation.
• Provides technical support for non-routine investigations (e.g., deviations, complaints) related to device assembly, including consultation on quality and stability.
• Prepares, reviews, approves, and provides 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.
• Ensures an accurate instruction set (tickets & procedures) describes the device assembly process as performed and the control strategy for discrete manufacturing steps.
• Owns the technical agenda for an assigned device assembly product, platform, or validation process.
• Leads risk management activities pertaining to assigned device assembly products and processes.
• Develops, monitors, and appropriately reacts to statistically based metrics in real time to assess device assembly process variability and capability.
• Supports and/or leads TSMS technical projects to ensure a successful device assembly start-up and improve process control, yield, product quality, and/or productivity; implements process changes and improvements through the technical agenda.
• Contributes to the stability strategy for LKC products.
• Serves 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.
• Serves as a technical mentor for TSMS engineers, scientists, and other disciplines.
• Provides audit and regulatory inspection (including PAI) support, as needed.
• Works within and leads cross-functional teams in a positive manner to implement TSMS objectives and deliver on business plan and quality objectives.
• Ensures 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 benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• 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