Director– Sterility Assurance

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive/maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) 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. 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. Provide mentoring leadership to site SMEs to help continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. 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. 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. Work with PR&D on new technology/platform development and implementation for pipeline products. 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. Basic Qualifications: BS Degree required. MS/PhD in a biological science preferred. 10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles preferred. Deep technical understanding of sterility assurance, from a science and compliance perspective. 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’s, policies, procedures, and guidelines relating to sterility assurance. Demonstrated experience influencing site and network leaders to advance technical agenda projects. Additional Information: Approximately 25% travel.

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