BioSpace, Inc.
Overview
Director Sterility Assurance role at Lilly. 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 role 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 aids in building technical capability at Lilly sites to meet business objectives and provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Lilly is a global healthcare leader focused on delivering innovative medicines and improving lives. Lilly is entering an exciting period of growth and is building a stronger Sterility Assurance function and capability across the network. Responsibilities
Assess differences in current sterility assurance programs across sites and drive harmonization. Work with site and cross-functional SMEs to drive cohesion; ensure control strategies are robust, compliant with regulatory expectations, and continuously improved. Serve as SME leader for a specific Sterility Assurance topic area across the network, including harmonization and knowledge sharing. Represent TS/MS on network governance forums; present Sterility Assurance programs and lessons learned to the network; establish forums to share learnings and best practices. Mentor site SMEs to build capability, especially at newer sites or where deep technical expertise is lacking. Build and grow capability in sterility assurance across the organization. Provide technical support to new sites/ filling lines during design and start-up to ensure sterility assurance programs meet requirements. Support significant sterility assurance investigations to identify root cause and implement corrective actions; share best practices and CAPAs across sites. Benchmark industry trends and regulatory guidance; participate in industry meetings and represent Lilly in external bodies related to Sterility Assurance; evaluate new technologies and share findings with the network. Collaborate with PR&D on new technology/platform development to ensure Manufacturing needs are met and control strategies are fit-for-purpose for robust commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside the Parenteral Network (e.g., PR&D, external CMOs, API manufacturing). Support regulatory interactions such as readiness activities for submissions and on-site inspections. Maintain a safe work environment and support all HSE Corporate Goals. Basic Qualifications
BS Degree required. MS/PhD in a biological science preferred. 10+ years experience in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles. 10+ years experience in parenteral manufacturing sterility assurance control systems including development, execution, operation, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current in industry developments (e.g., filling technology, Annex 1). Proficiency in data analysis, prioritization, attention to detail, decision-making, and complex problem-solving. Strong written and oral communication skills. Ability to mentor and develop scientists in sterility assurance and applied pharmaceutical microbiology. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Demonstrated experience influencing site and network leaders to advance technical agenda projects. Additional Preferences
Collaborate with senior technical staff to oversee new and existing facilities; assist with inspection readiness and investigations; guide root cause and CAPA across sites. Support establishment of a sterility assurance network or hub in global TSMS. Support health authority inspections as an expert in Sterility Assurance. Experience leading external committees or conferences to maintain Lillys leadership in sterility assurance. Work with engineering SMEs to maximize platform performance and minimize sterility risks. Strong scientific and practical thinking to select the best options after evaluation. Ability to influence personnel and management across the organization; work closely with Quality to enable internal audits that identify risks. Past experience creating effective relationships with internal and external stakeholders affecting sterility assurance success. Additional Information
Approximately 25% travel. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and offers accommodation options for applicants. Lilly is an EEO employer and does not discriminate on the basis of protected status. Actual compensation will depend on education, experience, and location. Lilly reserves the right to amend compensation and benefits programs at its discretion. #J-18808-Ljbffr
Director Sterility Assurance role at Lilly. 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 role 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 aids in building technical capability at Lilly sites to meet business objectives and provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Lilly is a global healthcare leader focused on delivering innovative medicines and improving lives. Lilly is entering an exciting period of growth and is building a stronger Sterility Assurance function and capability across the network. Responsibilities
Assess differences in current sterility assurance programs across sites and drive harmonization. Work with site and cross-functional SMEs to drive cohesion; ensure control strategies are robust, compliant with regulatory expectations, and continuously improved. Serve as SME leader for a specific Sterility Assurance topic area across the network, including harmonization and knowledge sharing. Represent TS/MS on network governance forums; present Sterility Assurance programs and lessons learned to the network; establish forums to share learnings and best practices. Mentor site SMEs to build capability, especially at newer sites or where deep technical expertise is lacking. Build and grow capability in sterility assurance across the organization. Provide technical support to new sites/ filling lines during design and start-up to ensure sterility assurance programs meet requirements. Support significant sterility assurance investigations to identify root cause and implement corrective actions; share best practices and CAPAs across sites. Benchmark industry trends and regulatory guidance; participate in industry meetings and represent Lilly in external bodies related to Sterility Assurance; evaluate new technologies and share findings with the network. Collaborate with PR&D on new technology/platform development to ensure Manufacturing needs are met and control strategies are fit-for-purpose for robust commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside the Parenteral Network (e.g., PR&D, external CMOs, API manufacturing). Support regulatory interactions such as readiness activities for submissions and on-site inspections. Maintain a safe work environment and support all HSE Corporate Goals. Basic Qualifications
BS Degree required. MS/PhD in a biological science preferred. 10+ years experience in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles. 10+ years experience in parenteral manufacturing sterility assurance control systems including development, execution, operation, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current in industry developments (e.g., filling technology, Annex 1). Proficiency in data analysis, prioritization, attention to detail, decision-making, and complex problem-solving. Strong written and oral communication skills. Ability to mentor and develop scientists in sterility assurance and applied pharmaceutical microbiology. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Demonstrated experience influencing site and network leaders to advance technical agenda projects. Additional Preferences
Collaborate with senior technical staff to oversee new and existing facilities; assist with inspection readiness and investigations; guide root cause and CAPA across sites. Support establishment of a sterility assurance network or hub in global TSMS. Support health authority inspections as an expert in Sterility Assurance. Experience leading external committees or conferences to maintain Lillys leadership in sterility assurance. Work with engineering SMEs to maximize platform performance and minimize sterility risks. Strong scientific and practical thinking to select the best options after evaluation. Ability to influence personnel and management across the organization; work closely with Quality to enable internal audits that identify risks. Past experience creating effective relationships with internal and external stakeholders affecting sterility assurance success. Additional Information
Approximately 25% travel. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and offers accommodation options for applicants. Lilly is an EEO employer and does not discriminate on the basis of protected status. Actual compensation will depend on education, experience, and location. Lilly reserves the right to amend compensation and benefits programs at its discretion. #J-18808-Ljbffr