Director– Sterility Assurance

Role Summary

Director– Sterility Assurance at Lilly. Provide oversight and drive/harmonize technical programs governing Sterility Assurance control strategies across the Lilly Parenteral Network, influence internal and external stakeholders, and build technical capability at Lilly sites. Offers 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 the sites and drive harmonization
• Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
• Represent TS/MS on network Science Lead Team and other governance forums. Present Sterility Assurance programs and learnings to align across sites; share best practices across sites.
• Provide mentoring leadership to site SMEs to build capability, particularly at newer sites or where deep technical expertise is lacking.
• Build, maintain, and grow capability across the organization in the sterility assurance space
• Provide technical support to new sites/ filling lines during design and start-up to ensure sterility assurance programs meet requirements
• Provide technical support for significant sterility assurance investigations, identify root cause, implement corrective actions, and share CAPAs across sites
• Benchmark industry trends and emerging regulatory guidance; represent Lilly on external bodies; assess new technologies and share with the network
• Work with PR&D on new technology/platform development and implementation to ensure manufacturing needs are met
• Provide ad-hoc technical support to Lilly organizations outside the PPN
• 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 a biological science preferred
• 10+ years’ experience in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred
• 10+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement in a highly regulated environment
• Deep technical understanding of sterility assurance from science and compliance perspective; current in industry developments
• Proficiency in data analysis; strong prioritization, attention to detail, decision-making, and problem-solving
• Strong written and oral communication skills
• Ability to mentor and develop scientists in sterility assurance and pharmaceutical microbiology
• Understanding of cGMPs, policies, procedures, and guidelines relating to sterility assurance
• Demonstrated experience influencing site and network leaders to advance technical agenda projects

Skills

• Scientific and practical thinking to evaluate options
• Influence across the organization; collaboration with quality and audits
• Relationship-building with internal and external stakeholders
• Inspection readiness and inspection execution expertise

Education

• BS required; MS/PhD preferred in biological sciences

Additional Requirements

• Approximately 25% travel