BioSpace, Inc.
Overview
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 work to discover and bring life-changing medicines to those who need them, improve disease management, and support communities through philanthropy and volunteerism. We are seeking a Sr. Principal/Advisor Sterility Assurance to provide oversight and harmonization of technical programs governing Sterility Assurance strategies across the Lilly Parenteral Product Network (PPN). Responsibilities
Provide oversight and drive harmonization of Sterility Assurance control strategies across the PPN. Influence peers globally and at the site level to ensure alignment with technical, quality, and regulatory guidance and business needs. Aid in building technical capability at Lilly sites to meet business objectives. Provide ad-hoc technical support to Lilly PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Support Central TS/MS Sterility Assurance initiatives and programs including global quality standards, sterility assurance work streams, new filling line startup, KPI development, and regulatory assessments. Assess differences in current sterility assurance programs across sites and drive harmonization; work with site SMEs to drive alignment. Ensure robust control strategies aligned with regulatory expectations and continuous improvement. Engage in governance forums to share learnings and best practices across sites and present case studies to site SMEs. Mentor site SMEs to build capability, particularly at newer sites or where advanced expertise is needed. Provide technical support for new sites / filling lines during design and startup to ensure compliance with sterility assurance requirements. Assist in building site-level capability to sustain compliance during commercial activities. Lead investigations into sterility assurance issues to determine root cause and implement corrective actions; share CAPA knowledge across sites. Assess new technologies to stay current with industry best practices and share insights across the network. Support preparation for and participation in regulatory interactions as needed. Basic Requirements
Bachelors or Masters degree in a biological science or engineering discipline (e.g., Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering). 5+ years experience in Parenteral Sterility Assurance / Microbiology or equivalent roles. Experience with parenteral manufacturing sterility assurance control systems development, execution, operation, and continuous improvement in a highly regulated environment. Additional Preferences
Education focused in microbiology. Strong technical understanding of sterility assurance from science and compliance perspectives; current with industry trends (e.g., filling technology, contamination control, Annex 1 interpretations). Data analysis proficiency, prioritization, attention to detail, decision-making, and complex problem-solving abilities. Strong written and oral communication skills. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Commitment to safe work practices and supporting HSE goals. Ability to collaborate with senior technical staff across the parenteral network TSMS group; support inspection readiness and investigations, and provide guidance on investigations and CAPAs. Support establishment of a sterility assurance network or hub within global TSMS. Experience with inspections by health authorities, either on-site or remote, as an expert in Sterility Assurance. Ability to influence personnel and management across the organization; strong collaboration with quality to identify risks in internal audits; ability to build effective relationships with internal and external stakeholders. Additional Information
Approximately 25% travel (domestic and international). Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation. 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. #J-18808-Ljbffr
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 work to discover and bring life-changing medicines to those who need them, improve disease management, and support communities through philanthropy and volunteerism. We are seeking a Sr. Principal/Advisor Sterility Assurance to provide oversight and harmonization of technical programs governing Sterility Assurance strategies across the Lilly Parenteral Product Network (PPN). Responsibilities
Provide oversight and drive harmonization of Sterility Assurance control strategies across the PPN. Influence peers globally and at the site level to ensure alignment with technical, quality, and regulatory guidance and business needs. Aid in building technical capability at Lilly sites to meet business objectives. Provide ad-hoc technical support to Lilly PR&D, QC Microbiology, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Support Central TS/MS Sterility Assurance initiatives and programs including global quality standards, sterility assurance work streams, new filling line startup, KPI development, and regulatory assessments. Assess differences in current sterility assurance programs across sites and drive harmonization; work with site SMEs to drive alignment. Ensure robust control strategies aligned with regulatory expectations and continuous improvement. Engage in governance forums to share learnings and best practices across sites and present case studies to site SMEs. Mentor site SMEs to build capability, particularly at newer sites or where advanced expertise is needed. Provide technical support for new sites / filling lines during design and startup to ensure compliance with sterility assurance requirements. Assist in building site-level capability to sustain compliance during commercial activities. Lead investigations into sterility assurance issues to determine root cause and implement corrective actions; share CAPA knowledge across sites. Assess new technologies to stay current with industry best practices and share insights across the network. Support preparation for and participation in regulatory interactions as needed. Basic Requirements
Bachelors or Masters degree in a biological science or engineering discipline (e.g., Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering). 5+ years experience in Parenteral Sterility Assurance / Microbiology or equivalent roles. Experience with parenteral manufacturing sterility assurance control systems development, execution, operation, and continuous improvement in a highly regulated environment. Additional Preferences
Education focused in microbiology. Strong technical understanding of sterility assurance from science and compliance perspectives; current with industry trends (e.g., filling technology, contamination control, Annex 1 interpretations). Data analysis proficiency, prioritization, attention to detail, decision-making, and complex problem-solving abilities. Strong written and oral communication skills. Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance. Commitment to safe work practices and supporting HSE goals. Ability to collaborate with senior technical staff across the parenteral network TSMS group; support inspection readiness and investigations, and provide guidance on investigations and CAPAs. Support establishment of a sterility assurance network or hub within global TSMS. Experience with inspections by health authorities, either on-site or remote, as an expert in Sterility Assurance. Ability to influence personnel and management across the organization; strong collaboration with quality to identify risks in internal audits; ability to build effective relationships with internal and external stakeholders. Additional Information
Approximately 25% travel (domestic and international). Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation. 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. #J-18808-Ljbffr