Eli Lilly and Company
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 the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We put people first and seek those determined to make life better for people around the world. Lilly is entering an exciting period of growth and is focused on delivering innovative medicines to patients around the world. The company is building a stronger Sterility Assurance function 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 the implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This role influences peers within Lilly globally and at the site level, and externally, to ensure strategies align with technical, quality and regulatory guidance, current expectations and business needs. The role also 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. 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 continuously improved. Ensure 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 of aspects of the topic area and facilitation of knowledge sharing. Represent TS/MS on network Science Lead Team and other governance forums. Ensure Sterility Assurance programs are presented to the network to align across sites, and share learnings and best practices. Facilitate forums and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build capability, particularly at newer sites or where deep technical expertise is lacking. Build, maintain, and grow capability across the organization in the sterility assurance space. Provide technical support to new sites/ filling lines during design and start-up to ensure sterility assurance programs and product requirements are supported at these sites. Provide technical support for significant sterility assurance investigations to identify root cause and implement corrective actions. Share best practices / learnings / CAPAs across sites. Benchmark industry trends and regulatory guidance; advance Lilly’s agenda in the field. Represent Lilly on external bodies related to Sterility Assurance and assess new technologies for currency with industry best practices. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D 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 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 and supporting 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 preferred. 10+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution and operation in a highly regulated environment preferred. Deep technical understanding of sterility assurance from science and compliance perspectives; current in technological and compliance developments across the parenteral manufacturing industry. Proficiency in data analysis, ability to prioritize, attention to detail, critical 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 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; provide guidance during inspections and support investigations to ensure timely root cause analysis and CAPA. Support the establishment of a sterility assurance network or hub in global TSMS. Support inspection preparation and execution during health authority inspections as an expert in Sterility Assurance. Experience leading external committees or conferences to maintain Lilly’s leadership in sterility assurance. Collaborate with engineering SMEs to maximize platform performance and minimize sterility risk. Strong scientific and practical thinking to evaluate options and select the best path forward. Ability to influence personnel and management across the organization. Close interaction with quality to enable internal audits that identify risks. Experience creating effective working relationships with internal and external stakeholders impacting sterility assurance success. Additional Information
Approximately 25% travel. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage ranges are provided as guidance and may vary by location and qualifications. Lilly offers a comprehensive benefits program including eligibility for a company 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible spending accounts; life insurance; time off; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and compensation practices apply to promotions or transfers. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If accommodation is required 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our groups include Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, Women’s Initiative for Leading at Lilly, enAble. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and location. The anticipated wage range for this position is $147,000 - $270,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program as described above. Lilly reserves the right to amend, modify, or terminate its compensation and benefits programs in its sole discretion. #WeAreLilly
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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 the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We put people first and seek those determined to make life better for people around the world. Lilly is entering an exciting period of growth and is focused on delivering innovative medicines to patients around the world. The company is building a stronger Sterility Assurance function 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 the implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This role influences peers within Lilly globally and at the site level, and externally, to ensure strategies align with technical, quality and regulatory guidance, current expectations and business needs. The role also 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. 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 continuously improved. Ensure 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 of aspects of the topic area and facilitation of knowledge sharing. Represent TS/MS on network Science Lead Team and other governance forums. Ensure Sterility Assurance programs are presented to the network to align across sites, and share learnings and best practices. Facilitate forums and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build capability, particularly at newer sites or where deep technical expertise is lacking. Build, maintain, and grow capability across the organization in the sterility assurance space. Provide technical support to new sites/ filling lines during design and start-up to ensure sterility assurance programs and product requirements are supported at these sites. Provide technical support for significant sterility assurance investigations to identify root cause and implement corrective actions. Share best practices / learnings / CAPAs across sites. Benchmark industry trends and regulatory guidance; advance Lilly’s agenda in the field. Represent Lilly on external bodies related to Sterility Assurance and assess new technologies for currency with industry best practices. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D 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 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 and supporting 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 preferred. 10+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution and operation in a highly regulated environment preferred. Deep technical understanding of sterility assurance from science and compliance perspectives; current in technological and compliance developments across the parenteral manufacturing industry. Proficiency in data analysis, ability to prioritize, attention to detail, critical 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 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; provide guidance during inspections and support investigations to ensure timely root cause analysis and CAPA. Support the establishment of a sterility assurance network or hub in global TSMS. Support inspection preparation and execution during health authority inspections as an expert in Sterility Assurance. Experience leading external committees or conferences to maintain Lilly’s leadership in sterility assurance. Collaborate with engineering SMEs to maximize platform performance and minimize sterility risk. Strong scientific and practical thinking to evaluate options and select the best path forward. Ability to influence personnel and management across the organization. Close interaction with quality to enable internal audits that identify risks. Experience creating effective working relationships with internal and external stakeholders impacting sterility assurance success. Additional Information
Approximately 25% travel. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage ranges are provided as guidance and may vary by location and qualifications. Lilly offers a comprehensive benefits program including eligibility for a company 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible spending accounts; life insurance; time off; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and compensation practices apply to promotions or transfers. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If accommodation is required 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our groups include Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network, Lilly India Network, Organization of Latinx at Lilly, PRIDE, Veterans Leadership Network, Women’s Initiative for Leading at Lilly, enAble. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and location. The anticipated wage range for this position is $147,000 - $270,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program as described above. Lilly reserves the right to amend, modify, or terminate its compensation and benefits programs in its sole discretion. #WeAreLilly
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