Overview In this role you will provide analytical support and technical direction for GMP laboratory activities, mentoring lab staff and shaping best practices across the site. You will oversee method transfer, validation, and data review while aligning with Lilly Global Quality Standards and regulatory expectations. You will collaborate with global Quality Labs to adopt testing and documentation improvements and drive continuous lab efficiency. You will help ensure inspection readiness and cross-functional collaboration to meet customer needs and maintain data integrity. This position offers a meaningful opportunity to influence quality and compliance in a fast-paced pharmaceutical environment.
Compensation / Benefits- comprehensive benefits package
- 401(k) eligibility
- medical, dental, vision benefits
- flexible benefits (FSA)
- life insurance and death benefits
- well-being benefits
Responsibilities- Provide analytical support, project leadership, and technical direction for laboratory analyses and data review
- Oversee transfer of analytical methods for marketed products, including documentation and testing execution
- Coordinate with global Quality Labs to adopt best practices for testing and investigations
- Ensure methods and procedures adhere to quality standards and regulatory requirements, including data integrity
- Support Lean Lab and efficient lab operations
- Network with other areas to share knowledge and meet customer needs
- Define and execute inspection readiness activities in QC laboratories
- Interact effectively with auditors and business partners
Key requirements- GMP laboratory experience including analytical testing, method transfer, and method validation
- Experience with enterprise chromatography systems and standalone COTS testing instruments
- Experience with LC instruments
- Experience with statistics and data analysis software, especially data visualization
- Strong technical mentoring ability
- Effective written and oral communication
- Cross-functional collaboration
- GMP laboratory practices
- Analytical testing and method transfer/validation
- Chromatography systems
