Director– Sterility Assurance - Eli Lilly and Company

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.

• 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

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.

• 10+ years’ experience in parenteral manufacturing sterility assurance control systems – 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’s, policies, procedures, and guidelines relating to sterility assurance

• Demonstrated experience influencing site and network leaders to advance technical agenda projects

Additional Preferences:

• Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.

• Support the establishment of a sterility assurance network or hub in global TSMS

• Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance

• Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space

• Work with engineering SME’s to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance

• Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.

• Strong capability to influence personnel and management across the organization

• Close interaction with quality to enable internal audits that identify risks

• Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.

Additional Information:

• Approximately 25% travel

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