BioSpace
Overview
Join to apply for the
Director– Sterility Assurance
role at BioSpace. Lilly is a global healthcare leader focused on delivering innovative medicines and building sterility assurance capabilities across the Parenteral Network. This role provides oversight and drives harmonization of sterility assurance programs, influences peers globally and at sites, and supports capability-building for sustained business objectives. The position may provide 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 sites and drive harmonization. Collaborate with site and cross-functional SMEs to drive cohesion; ensure control strategies are robust, compliant with regulatory expectations, and continuously improved. Assume SME leadership for a specific Sterility Assurance topic area across the network and facilitate knowledge sharing. Represent TS/MS on network Science Lead Team and governance forums; present Sterility Assurance programs and learnings to the network; establish forums to share best practices and case studies with site SMEs. Provide mentoring to site SMEs to build capability, especially at newer sites or where deep technical expertise is lacking. Build, maintain, and grow capability across the organization in sterility assurance. Provide technical support to new sites during design and start-up to ensure sterility requirements are met; assist during early capability development. Support significant sterility assurance investigations to identify root causes and implement CAPAs; share lessons across sites. Benchmark industry trends and regulatory guidance; attend industry/regulatory meetings; represent Lilly in external bodies related to Sterility Assurance; assess new technologies and share with the network. Work with PR&D on new technology/platform development and ensure control strategies meet manufacturing needs. Provide ad-hoc technical support to Lilly organizations outside of the Parenteral Network, including PR&D, external contract manufacturing, and API manufacturing. Engage in regulatory interactions such as RtQ submissions and on-site inspections; ensure preparation and readiness. Maintain a safe work environment and support all health, safety, and environmental 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—development, execution, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current knowledge of industry trends (e.g., filling technology, Annex 1 interpretation). Proficiency in data analysis, prioritization, attention to detail, decision-making, and complex problem-solving. Strong written and oral communication skills; ability to mentor scientists in sterility assurance and pharmaceutical microbiology. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Experience influencing site and network leadership to advance technical agendas. Additional Preferences
Collaborate with senior technical staff in the parenteral network TSMS group to oversee new and existing facilities; support inspection readiness and investigations; provide guidance on root cause and CAPA. Support the establishment of a sterility assurance network or hub in global TSMS. Assist during health authority inspections as a Sterility Assurance expert. Experience leading external committees or conferences to keep Lilly at the forefront of sterility assurance. Work with engineering SMEs to optimize Lilly platforms and minimize sterility risk. Demonstrate scientific and practical thinking to select optimal options after evaluation; strong ability to influence across the organization. Collaborate with quality to enable internal audits that identify risks; build effective relationships with stakeholders. Past experience creating working relationships with internal and external stakeholders to support sterility assurance success. Additional Information
Approximately 25% travel. Lilly compensation details: base salary range and bonus eligibility depend on qualifications and performance. A comprehensive benefits program includes 401(k), pension, medical/dental/vision coverage, flexible benefits, life and disability insurance, paid time off, and well-being programs. Compensation is subject to change and Lilly reserves the right to amend programs. Lilly is an equal opportunity employer and provides accommodations for applicants with disabilities. If you require an accommodation to submit a resume, please submit an accommodation request. We value diversity and inclusion; Lilly does not discriminate on age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) support a diverse workforce. Actual compensation will depend on education, experience, skills, and location. Typical compensation ranges for similar roles may be provided; compensation decisions are at Lilly’s discretion. #WeAreLilly
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Join to apply for the
Director– Sterility Assurance
role at BioSpace. Lilly is a global healthcare leader focused on delivering innovative medicines and building sterility assurance capabilities across the Parenteral Network. This role provides oversight and drives harmonization of sterility assurance programs, influences peers globally and at sites, and supports capability-building for sustained business objectives. The position may provide 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 sites and drive harmonization. Collaborate with site and cross-functional SMEs to drive cohesion; ensure control strategies are robust, compliant with regulatory expectations, and continuously improved. Assume SME leadership for a specific Sterility Assurance topic area across the network and facilitate knowledge sharing. Represent TS/MS on network Science Lead Team and governance forums; present Sterility Assurance programs and learnings to the network; establish forums to share best practices and case studies with site SMEs. Provide mentoring to site SMEs to build capability, especially at newer sites or where deep technical expertise is lacking. Build, maintain, and grow capability across the organization in sterility assurance. Provide technical support to new sites during design and start-up to ensure sterility requirements are met; assist during early capability development. Support significant sterility assurance investigations to identify root causes and implement CAPAs; share lessons across sites. Benchmark industry trends and regulatory guidance; attend industry/regulatory meetings; represent Lilly in external bodies related to Sterility Assurance; assess new technologies and share with the network. Work with PR&D on new technology/platform development and ensure control strategies meet manufacturing needs. Provide ad-hoc technical support to Lilly organizations outside of the Parenteral Network, including PR&D, external contract manufacturing, and API manufacturing. Engage in regulatory interactions such as RtQ submissions and on-site inspections; ensure preparation and readiness. Maintain a safe work environment and support all health, safety, and environmental 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—development, execution, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current knowledge of industry trends (e.g., filling technology, Annex 1 interpretation). Proficiency in data analysis, prioritization, attention to detail, decision-making, and complex problem-solving. Strong written and oral communication skills; ability to mentor scientists in sterility assurance and pharmaceutical microbiology. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Experience influencing site and network leadership to advance technical agendas. Additional Preferences
Collaborate with senior technical staff in the parenteral network TSMS group to oversee new and existing facilities; support inspection readiness and investigations; provide guidance on root cause and CAPA. Support the establishment of a sterility assurance network or hub in global TSMS. Assist during health authority inspections as a Sterility Assurance expert. Experience leading external committees or conferences to keep Lilly at the forefront of sterility assurance. Work with engineering SMEs to optimize Lilly platforms and minimize sterility risk. Demonstrate scientific and practical thinking to select optimal options after evaluation; strong ability to influence across the organization. Collaborate with quality to enable internal audits that identify risks; build effective relationships with stakeholders. Past experience creating working relationships with internal and external stakeholders to support sterility assurance success. Additional Information
Approximately 25% travel. Lilly compensation details: base salary range and bonus eligibility depend on qualifications and performance. A comprehensive benefits program includes 401(k), pension, medical/dental/vision coverage, flexible benefits, life and disability insurance, paid time off, and well-being programs. Compensation is subject to change and Lilly reserves the right to amend programs. Lilly is an equal opportunity employer and provides accommodations for applicants with disabilities. If you require an accommodation to submit a resume, please submit an accommodation request. We value diversity and inclusion; Lilly does not discriminate on age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) support a diverse workforce. Actual compensation will depend on education, experience, skills, and location. Typical compensation ranges for similar roles may be provided; compensation decisions are at Lilly’s discretion. #WeAreLilly
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