Overview In this role you will support gene therapy drug product labeling and packaging operations during tech transfer and start-up, then maintain validated processes for commercial supply. You will lead technical oversight, collaborate with cross-functional teams, and drive metrics to ensure process capability and control. You'll tackle deviations, investigations, and regulatory documentation to support safe, compliant packaging. This is a hands-on, startup-to-operations position at Lilly's advanced LP2 site, with a focus on high-quality, scalable manufacturing. You will help shape the labeling and packaging strategy across global teams and suppliers.
Compensation / Benefits- 401(k)
- health, dental, vision benefits
- flexible benefits (FSA)
- vacation and time off
- life insurance
- well-being programs
Responsibilities- Understand labeling and packaging science for drug products, including interactions among chemistry, equipment, aseptic processes, and container closure systems
- Provide technical oversight for labeling and packaging materials
- Offer technical support to operations regarding materials, equipment, and processes
- Lead technical evaluations and root cause analysis to resolve issues
- Conduct risk assessments for labeling and packaging operations and suppliers
- Support start-up activities such as tech transfer and process validation
- Assist with non-routine investigations (deviations, complaints) and provide quality input
- Prepare and review technical documents (change controls, regulatory submissions, validation protocols, SOPs, etc.)
- Ensure accurate instructions and control strategies for manufacturing steps
- Support or own the technical agenda for product or validation processes
- Develop and monitor real-time metrics to assess process variability and capability
- Serve as the technical interface external to the LP2 site and provide audit support
- Collaborate with cross-functional teams and influence partners across global packaging sites
- Maintain a safe working environment and participate in safety initiatives
Key requirements- B.S. in engineering, packaging science, or related field
- 3+ years of experience in a manufacturing organization focused on labeling and packaging
- Authorized to work in the United States full-time (no sponsorship provided)
- strong interpersonal and teamwork abilities
- high attention to detail
- self-management and organizational skills
- labeling and packaging
- process validation
- technical transfer
