Eli Lilly and Company
Associate Director – TSMS Sterility Assurance
Eli Lilly and Company, Pleasant Prairie, Wisconsin, United States, 53158
Associate Director – TSMS Sterility Assurance
We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Responsibilities The Associate Director TS/MS – Sterility Assurance is responsible for the oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The role is responsible for leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing, specifically the formulation/filling/inspection of pharmaceutical products. This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards related to sterility assurance. Additionally, this position requires the ability to multitask/prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement solutions. Key Objectives/Deliverables Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. Technical and defendable contamination control strategy design and execution Performance management and development of staff Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives Technical review and approval for site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues. Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning. Maintain metrics to measure performance against business objectives and make necessary changes to improve performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level. Provide technical guidance to the Process Team for sterility assurance programs and for root cause investigations related to sterility assurance programs. Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs. Basic Requirements BS Degree required. MS/PhD in a biological science preferred 10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles 10+ years' experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment Deep technical understanding of sterility assurance, from a science and compliance perspective. Minimum 3 years of management or leadership experience, including leading or working effectively with a cross functional group Teamwork and interpersonal skills Independent critical decision making, complex problem solving, and prioritization skills Multi-tasking and communications skills Ability to influence diverse groups Additional Skills/Preferences Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Additional relevant experience (greater than 5 years) in any of the following associated disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories Experience with syringe technology and isolator filling technology Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. 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.
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We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Responsibilities The Associate Director TS/MS – Sterility Assurance is responsible for the oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The role is responsible for leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing, specifically the formulation/filling/inspection of pharmaceutical products. This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards related to sterility assurance. Additionally, this position requires the ability to multitask/prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement solutions. Key Objectives/Deliverables Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. Technical and defendable contamination control strategy design and execution Performance management and development of staff Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives Technical review and approval for site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues. Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning. Maintain metrics to measure performance against business objectives and make necessary changes to improve performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level. Provide technical guidance to the Process Team for sterility assurance programs and for root cause investigations related to sterility assurance programs. Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs. Basic Requirements BS Degree required. MS/PhD in a biological science preferred 10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles 10+ years' experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment Deep technical understanding of sterility assurance, from a science and compliance perspective. Minimum 3 years of management or leadership experience, including leading or working effectively with a cross functional group Teamwork and interpersonal skills Independent critical decision making, complex problem solving, and prioritization skills Multi-tasking and communications skills Ability to influence diverse groups Additional Skills/Preferences Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Additional relevant experience (greater than 5 years) in any of the following associated disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories Experience with syringe technology and isolator filling technology Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. 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.
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