Associate Director – TSMS Sterility Assurance

Role Summary

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 leads and mentors a technical staff, applying expertise in parenteral aseptic processing for drug product manufacturing (formulation, filling, inspection). The role provides guidance on priorities, manages routine production support activities, and balances technical project work with program oversight, while ensuring compliance with cGMPs and applicable regulatory 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, and participate in tactical and strategic business planning.
• Maintain metrics to measure performance against business objectives and implement improvements.
• 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 for potential microbial, endotoxin, and particulate contamination.
• Ensure environmental monitoring, aseptic process simulations, facility cleaning, sanitization, sterility assurance risk management, and related programs are followed on the manufacturing floor.
• Provide technical guidance to the Process Team for sterility assurance programs and root cause investigations.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.

Qualifications

• Required: BS Degree.
• Preferred: MS/PhD in a biological science.
• Required: 10+ years’ experience in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
• Required: 10+ years' experience in parenteral manufacturing sterility assurance control systems—development, execution, operation, and continuous improvement in a highly regulated environment.
• Required: Deep technical understanding of sterility assurance from science and compliance perspectives; up-to-date with industry developments (e.g., filling technology, Annex 1 interpretation).
• Required: Minimum 3 years of management or leadership experience, including cross-functional collaboration.
• Required: Teamwork and interpersonal skills; independent critical decision making, complex problem solving, prioritization; strong multi-tasking and communication skills; ability to influence diverse groups.
• Required: Ability to influence diverse groups.

Skills

• Data analysis and statistical interpretation.
• Strong written and oral communication.
• Mentoring and development of scientists in sterility assurance and applied pharmaceutical microbiology.
• Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance.
• Ability to influence site and network leaders to advance technical agenda projects.
• Scientific and practical thinking to evaluate options and select best courses of action.
• Ability to influence personnel and management across the organization.
• Experience in related disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories (advantageous).
• Experience with syringe technology and isolator filling technology (advantageous).

Education

• BS Degree required.
• MS/PhD in a biological science preferred.

Additional Requirements

• Role is Monday through Friday; may require flexible hours to support production schedules, shutdowns, etc. Some travel to other manufacturing sites and corporate office may be required.