Scientist / Principal Scientist – TSMS PAR

Lilly • Pleasant Prairie, WI

2d • Onsite

About The Position

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.

Requirements

• Bachelor's degree or higher in engineering, packaging science, or related field
• 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, 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

• 2+ years' experience in cGMP manufacturing preferred (validation, engineering, TSMS, operations, QA, etc.)
• Pharmaceutical and/or medical device manufacturing experience
• Root Cause Investigation Experience
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise/MasterControl, electronic batch records, and SAP
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills

Responsibilities

• Support the assigned Process Team (formulation, filling, or VI) as TSMS representative.
• Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
• Represent Lilly Kenosha County TSMS team for internal and external communications on a regular basis
• Lead risk management activities as it pertains to product/process.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
• Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity
• Serve as interface with upstream suppliers and parenteral product networks
• Drive stability strategy for Lilly Kenosha County products.
• Provide Audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

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