BioSpace
Associate Director – TSMS Sterility Assurance
BioSpace, Pleasant Prairie, Wisconsin, United States, 53158
Overview
Associate Director – TSMS Sterility Assurance. The role provides oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The position leads and mentors a technical staff and covers parenteral aseptic processing as it relates to drug product manufacturing, including formulation, filling, and inspection of pharmaceutical products. The Associate Director manages priorities for direct reports, balances routine production support with technical project implementation and program oversight. Responsibilities
Maintain a safe work environment, lead safety initiatives, and support all HSE Corporate and Site Goals. Design and execute a contamination control strategy that is technically sound and defendable. Manage performance and development of staff. Collaborate within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives. Review and approve 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. Engage with internal and external networks to share best practices and contribute to strategic and tactical business planning. Maintain metrics to measure performance against objectives and implement improvements as needed. Use sterility assurance risk management to evaluate manufacturing processes and controls against potential contamination. Ensure environmental monitoring, aseptic process simulations, cleaning, sanitization, and sterility assurance programs are followed on the manufacturing floor. Provide technical guidance to the Process Team for sterility assurance programs and root cause investigations related to sterility issues. Analyze microbial and manufacturing data using statistical methods to identify trends and opportunities for continuous improvement. Basic Requirements
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, operation, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current with technology and regulatory developments in parenteral manufacturing (e.g., filling technology, Annex 1 interpretation). Minimum 3 years of management or leadership experience, including cross-functional collaboration. Strong teamwork, interpersonal, decision-making, and prioritization skills; ability to multitask and communicate effectively. Ability to influence diverse groups. Additional Skills/Preferences
Proficiency in data analysis; strong attention to detail and decision-making abilities; complex problem-solving skills. 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 related to sterility assurance. Experience influencing site and network leaders to advance technical agenda projects. Ability to evaluate options and select the best with thorough evaluation. Ability to influence personnel and management across the organization. Additional relevant experience in Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories (5+ years) and experience with syringe technology and isolator filling technology. Additional Information
Role is Monday through Friday; flexible to accommodate production schedules, shutdowns, etc. Occasional extended hours or off-hour work may be required. Some travel may be required to other manufacturing sites and Lilly’s corporate office. For GMP purposes, job requirements may change over time; consult with your supervisor regarding actual responsibilities. Lilly is an equal opportunity employer (EEO). Lilly provides accommodations for applicants with disabilities upon request in the application process. See the accommodation request form for details. Lilly reserves the right to amend compensation and benefits at its discretion.
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Associate Director – TSMS Sterility Assurance. The role provides oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The position leads and mentors a technical staff and covers parenteral aseptic processing as it relates to drug product manufacturing, including formulation, filling, and inspection of pharmaceutical products. The Associate Director manages priorities for direct reports, balances routine production support with technical project implementation and program oversight. Responsibilities
Maintain a safe work environment, lead safety initiatives, and support all HSE Corporate and Site Goals. Design and execute a contamination control strategy that is technically sound and defendable. Manage performance and development of staff. Collaborate within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives. Review and approve 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. Engage with internal and external networks to share best practices and contribute to strategic and tactical business planning. Maintain metrics to measure performance against objectives and implement improvements as needed. Use sterility assurance risk management to evaluate manufacturing processes and controls against potential contamination. Ensure environmental monitoring, aseptic process simulations, cleaning, sanitization, and sterility assurance programs are followed on the manufacturing floor. Provide technical guidance to the Process Team for sterility assurance programs and root cause investigations related to sterility issues. Analyze microbial and manufacturing data using statistical methods to identify trends and opportunities for continuous improvement. Basic Requirements
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, operation, and continuous improvement in a highly regulated environment. Deep technical understanding of sterility assurance from science and compliance perspectives; current with technology and regulatory developments in parenteral manufacturing (e.g., filling technology, Annex 1 interpretation). Minimum 3 years of management or leadership experience, including cross-functional collaboration. Strong teamwork, interpersonal, decision-making, and prioritization skills; ability to multitask and communicate effectively. Ability to influence diverse groups. Additional Skills/Preferences
Proficiency in data analysis; strong attention to detail and decision-making abilities; complex problem-solving skills. 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 related to sterility assurance. Experience influencing site and network leaders to advance technical agenda projects. Ability to evaluate options and select the best with thorough evaluation. Ability to influence personnel and management across the organization. Additional relevant experience in Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories (5+ years) and experience with syringe technology and isolator filling technology. Additional Information
Role is Monday through Friday; flexible to accommodate production schedules, shutdowns, etc. Occasional extended hours or off-hour work may be required. Some travel may be required to other manufacturing sites and Lilly’s corporate office. For GMP purposes, job requirements may change over time; consult with your supervisor regarding actual responsibilities. Lilly is an equal opportunity employer (EEO). Lilly provides accommodations for applicants with disabilities upon request in the application process. See the accommodation request form for details. Lilly reserves the right to amend compensation and benefits at its discretion.
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