Associate Director – TSMS Sterility Assurance

Role Summary

Associate Director TSMS Sterility Assurance role responsible for overseeing Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing, leading technical staff, and ensuring compliance with cGMPs and sterility standards.

Responsibilities

• Responsible for maintaining a safe work environment, leading safety initiatives, and 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‚Äôs 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.

Qualifications

• BS Degree required.
• MS/PhD in a biological science preferred
• 10+ years‚Äô experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles
• 10+ years' experience in parenteral manufacturing sterility assurance control systems ‚Äì 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. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
• 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

• 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‚Äôs, 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

Additional Information

• Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Some travel may be required to other manufacturing sites and Lilly‚Äôs corporate office