Director– Sterility Assurance

Role Summary

Director– Sterility Assurance

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 appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
• Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
• Building, maintaining, and growing capability across the organization in the sterility assurance space
• Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
• Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
• Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly‚Äôs position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
• Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit-for-purpose for robust and compliant commercial manufacturing.
• Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
• Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals

Qualifications

• BS Degree required.
• MS/PhD in a biological science preferred.
• 10+ years‚Äô experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
• 10+ years‚Äô experience in parenteral manufacturing sterility assurance control systems ‚Äì development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
• Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
• Strong written and oral communication skills
• Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
• Understanding of cGMP‚Äôs, policies, procedures, and guidelines relating to sterility assurance
• Demonstrated experience influencing site and network leaders to advance technical agenda projects

Skills

• Leadership and mentoring
• Strategic program management
• Regulatory and quality compliance knowledge
• Technical proficiency in sterility assurance and environmental monitoring
• Cross-functional collaboration and communication

Education

• BS Degree required; advanced degree preferred

Additional Requirements

• Approximately 25% travel