Principal Scientist - Visual Inspection

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.

About the role

The IPM Visual Inspection Steward is a technical position that develops and implements a technical agenda. Primary objectives include reliable and compliant manufacturing of parenteral products and improvement of the process control strategy focusing on the visual inspection process.

Responsibilities

• Drive the technical agenda and mentor technical staff as the TS/MS Visual Inspection Steward, reporting directly to the IPM Syringe Plant TS/MS Senior Director.
• Own a technical agenda for the syringe visual inspection platform, including Manual, Semi-Automatic, and Automatic inspection, covering continuous improvement, compliance initiatives, process control, yield, and productivity.
• Serve as a technical mentor for Scientists, leaders, and other disciplines, providing guidance to the TS/MS group.
• Provide technical support for non-routine investigations (e.g., deviation, process removal), including consultation on quality issues, resort recommendations, and process changes.
• Prepare, review, and approve relevant technical documents such as Change Controls, Deviations, and Procedures.
• Support identification and development of new inspection technologies and techniques, and implement improvements for existing commercial manufacturing processes.
• Understand and influence the manufacturing control strategy for various operational areas.
• Drive control, capability, productivity, and continuous improvement for the process.
• Network and collaborate with global and other parenteral sites to understand best practices and share knowledge.
• Support site inspection readiness and execution, with potential direct interaction with Regulatory Agencies during site inspections.

Requirements

• Bachelor’s Degree in scientific disciplines such as Material Science, Chemistry, Biology, Pharmacy, Engineering, or equivalent.
• 3+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• 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.

Skills

• Strong technical aptitude and ability to train and mentor others.
• Proven teamwork and interpersonal skills.
• Problem-solving and independent decision-making skills.
• Oral and written communication skills that demonstrate an ability to effectively communicate with all levels of the organization.
• Ability to influence diverse groups.
• Previous experience with deviation and change management systems.
• Previous experience with regulatory agencies during site inspections.
• Previous experience with visual inspection or defect classification – components incoming inspection and/or drug product inspection.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• 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).
• Company bonus (depending, in part, on company and individual performance).

Pay

The anticipated wage for this position is $102,000 - $171,600.

Employee Resource Groups

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN), and Women’s Initiative for Leading at Lilly (WILL).