BioSpace
Director, Parenteral 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.
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, ensuring control strategies are robust, consistent with regulatory and compliance expectations, and continuously improved.
Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization and facilitation of knowledge across the network.
Represent TS/MS on network Science Lead Team and other governance forums; present Sterility Assurance programs to align across sites; share best practices and case studies.
Provide mentoring leadership to site SMEs, building capability especially at newer sites or sites lacking deep technical expertise.
Build, maintain, and grow capability across the organization in the sterility assurance space.
Provide technical support to new sites or filling lines during design and start‑up activities, ensuring sterility assurance programs and process/product requirements are supported.
Provide technical support for significant sterility assurance investigations to identify root cause and implement corrective actions; share best practices/CAPAs across sites.
Benchmark industry trends and emerging regulatory guidance; represent Lilly on external bodies related to Sterility Assurance; assess new technologies and share insights to maintain industry best practice.
Work with PR&D on new technology/platform development and implementation for pipeline products; influence agenda to ensure manufacturing needs are met with fit‑for‑purpose control strategies.
Provide ad‑hoc technical support to Lilly organizations outside the PPN, including PR&D, external contract manufacturing, and non‑sterile drug substance (API) manufacturing.
Engage in regulatory interactions such as RtQ of 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 of experience in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles.
10+ years of experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement in a highly regulated environment.
Deep technical understanding of sterility assurance from a science and compliance perspective; current knowledge of technological and compliance developments across the parenteral manufacturing industry.
Proficiency in data analysis, ability to prioritize, attention to detail, critical decision‑making skills, and complex problem‑solving abilities.
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 relating to sterility assurance.
Demonstrated experience influencing site and network leaders to advance technical agenda projects.
Additional Preferences
Work closely with senior technical staff to provide full oversight to new and existing facilities; support inspection readiness and preparation, investigations, and root‑cause CAPA development.
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 inspections as an expert in Sterility Assurance.
Experience leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space.
Work with engineering SMEs to support Lilly platforms, maximizing performance and minimizing sterility assurance risk.
Strong capability to influence personnel and management across the organization.
Close interaction with quality to enable internal audits that identify risks.
Past experience creating effective working relationships with all levels across internal and external stakeholders impacting sterility assurance success.
Additional Information
Approximately 25% travel.
Salary range: $133,500 - $246,400 (based on qualifications).
Full‑time employees will also be eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, leave of absence benefits, and well‑being programs.
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume for this position, please complete the accommodation request form at
https://careers.lilly.com/us/en/workplace-accommodation . This is for individuals to request an accommodation as part of the application process; responses will not be provided for other correspondence.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of 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.
Location: Indianapolis, IN. Compensation may vary by education, experience, skills, and geographic location.
#J-18808-Ljbffr
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, ensuring control strategies are robust, consistent with regulatory and compliance expectations, and continuously improved.
Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization and facilitation of knowledge across the network.
Represent TS/MS on network Science Lead Team and other governance forums; present Sterility Assurance programs to align across sites; share best practices and case studies.
Provide mentoring leadership to site SMEs, building capability especially at newer sites or sites lacking deep technical expertise.
Build, maintain, and grow capability across the organization in the sterility assurance space.
Provide technical support to new sites or filling lines during design and start‑up activities, ensuring sterility assurance programs and process/product requirements are supported.
Provide technical support for significant sterility assurance investigations to identify root cause and implement corrective actions; share best practices/CAPAs across sites.
Benchmark industry trends and emerging regulatory guidance; represent Lilly on external bodies related to Sterility Assurance; assess new technologies and share insights to maintain industry best practice.
Work with PR&D on new technology/platform development and implementation for pipeline products; influence agenda to ensure manufacturing needs are met with fit‑for‑purpose control strategies.
Provide ad‑hoc technical support to Lilly organizations outside the PPN, including PR&D, external contract manufacturing, and non‑sterile drug substance (API) manufacturing.
Engage in regulatory interactions such as RtQ of 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 of experience in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles.
10+ years of experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement in a highly regulated environment.
Deep technical understanding of sterility assurance from a science and compliance perspective; current knowledge of technological and compliance developments across the parenteral manufacturing industry.
Proficiency in data analysis, ability to prioritize, attention to detail, critical decision‑making skills, and complex problem‑solving abilities.
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 relating to sterility assurance.
Demonstrated experience influencing site and network leaders to advance technical agenda projects.
Additional Preferences
Work closely with senior technical staff to provide full oversight to new and existing facilities; support inspection readiness and preparation, investigations, and root‑cause CAPA development.
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 inspections as an expert in Sterility Assurance.
Experience leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space.
Work with engineering SMEs to support Lilly platforms, maximizing performance and minimizing sterility assurance risk.
Strong capability to influence personnel and management across the organization.
Close interaction with quality to enable internal audits that identify risks.
Past experience creating effective working relationships with all levels across internal and external stakeholders impacting sterility assurance success.
Additional Information
Approximately 25% travel.
Salary range: $133,500 - $246,400 (based on qualifications).
Full‑time employees will also be eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, leave of absence benefits, and well‑being programs.
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume for this position, please complete the accommodation request form at
https://careers.lilly.com/us/en/workplace-accommodation . This is for individuals to request an accommodation as part of the application process; responses will not be provided for other correspondence.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of 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.
Location: Indianapolis, IN. Compensation may vary by education, experience, skills, and geographic location.
#J-18808-Ljbffr