Director

• 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
• 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’s 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

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