Director– Sterility Assurance

Role Summary

Director– Sterility Assurance at Lilly. Oversight and harmonization of Sterility Assurance programs across the Lilly Parenteral Network, influencing internal and external stakeholders to ensure strategies align with technical, quality, and regulatory guidance. Builds technical capability at Lilly sites and provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance manufacturing.

Responsibilities

• Assess differences in current sterility assurance programs across sites and drive harmonization
• Work with site and multi-functional SMEs to drive cohesion; ensure robust control strategies aligned with regulatory and compliance expectations and continuously improved
• Assume SME leadership for specific Sterility Assurance topic areas across the network
• Represent TS/MS on network governance forums; present Sterility Assurance programs and learnings to align across sites
• Provide mentoring leadership to site SMEs to build capability, especially at newer sites
• Build and grow capability across the organization in sterility assurance
• Provide technical support to new sites during design and start-up to ensure sterility assurance requirements are met
• Provide technical support for significant sterility investigations; share CAPAs and best practices across sites
• Benchmark industry trends and regulatory guidance; represent Lilly on external bodies and assess new technologies
• Collaborate with PR&D on new technology/platform development for pipeline products and ensure control strategies meet manufacturing needs
• Provide ad-hoc technical support to Lilly organizations outside of PPN (PR&D, external contract manufacturing, API)
• Engage in regulatory interactions such as RtQ of submissions and on-site inspections
• Maintain a safe work environment and support HSE corporate goals

Qualifications

• BS Degree required
• MS/PhD in biological science preferred
• 10+ years‚Äô experience in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles
• 10+ years‚Äô experience in parenteral manufacturing sterility assurance control systems
• Deep technical understanding of sterility assurance; up-to-date with industry developments
• Proficiency in data analysis, prioritization, attention to detail, and complex problem-solving
• Strong written and oral communication skills
• Ability to mentor and develop scientists in sterility assurance and applied pharmaceutical microbiology
• Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance
• Demonstrated ability to influence site and network leaders to advance technical agenda projects

Skills

• Leadership and mentoring
• Technical expertise in sterility assurance and regulatory compliance
• Cross-functional collaboration and stakeholder management
• Regulatory and industry benchmarking
• Technical problem solving and decision making

Education

• BS required; MS/PhD preferred in biological sciences or related field

Additional Requirements

• Approximately 25% travel