Labeling and Packaging Scientist - Advanced Therapies Manufacturing

Lilly • Lebanon, IN

1d • $67,500 - $173,800

About The Position

Lilly is hiring a Labeling and Packaging Scientist for its Technical Services/Manufacturing Scientist (TS/MS) team at its advanced genetic medicines manufacturing facility in Lebanon, Indiana. The site is a greenfield facility designed to supply clinical and commercial products using next-generation manufacturing technologies and advanced data collection and analysis platforms. The TS/MS team owns technology transfer, process validation, and process stewardship.

The role initially supports internal and external technical transfer and process validation for gene therapy drug product labeling and packaging. After commercial production begins, the scientist will help maintain validated processes, establish and monitor metrics and methods for process capability and control, harmonize control strategies across process teams, evaluate process improvements, and serve as an escalation point for day-to-day operational issues. The position develops and implements a technical agenda and provides technical leadership for labeling and packaging processes at the LP2 site.

The scientist provides technical oversight and operational support for labeling and packaging materials, equipment, and processes; leads technical evaluations, troubleshooting, root-cause analysis, and risk assessments; and supports startup activities and investigations. The role also prepares, reviews, approves, or advises on technical and quality documentation, maintains accurate process instructions and control strategies, monitors statistically based process metrics, serves as an external technical interface, supports audits, and works with cross-functional and global packaging partners. Off-hours response to operational issues may be required, and travel is minimal.

Requirements

• Bachelor of Science degree in engineering, packaging science, or a related field.
• At least 3 years of experience in a manufacturing organization focused on labeling and packaging.
• Authorization to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• Pharmaceutical labeling and packaging manufacturing experience.
• Root-cause investigation experience.
• Ability to work independently or as part of a team to resolve issues.
• Strong attention to detail.
• Proficiency with computer systems, including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.
• Knowledge and understanding of manufacturing processes.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.

Responsibilities

• Understand the scientific principles of drug-product labeling and packaging, including interactions among chemistry, equipment, aseptic processes, and container closure systems.
• Provide technical oversight for labeling and packaging materials and technical support to operations concerning materials, equipment, and processes.
• Lead technical evaluations, troubleshooting, problem resolution, and root-cause analysis.
• Lead risk assessments of labeling and packaging operations and material suppliers.
• Provide technical support for startup activities, including technology transfer and process validation.
• Support non-routine investigations, such as deviations and complaints, including consultation on quality and stability.
• Prepare, review, approve, or support technical documents such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, and APRs.
• Ensure that tickets and procedures accurately describe the process as performed and the control strategy for discrete manufacturing steps.
• Support or own the technical agenda for the product or validation process.
• Develop and monitor statistically based metrics, and respond appropriately in real time to assess process variability and capability.
• Serve as a technical interface outside the LP2 site and provide audit support as needed.
• Work within or lead cross-functional teams to implement TS/MS objectives and meet business-plan and quality objectives.
• Collaborate with and influence partners across global packaging sites and teams in a product supply chain.
• Support a safe working environment by following safety rules and participating in activities that improve safety culture.
• Respond off shift to operational issues when required; provide off-hours support by request.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level