Associate Director – TSMS Sterility Assurance

Associate Director – TSMS Sterility Assurance

Join to apply for the Associate Director – TSMS Sterility Assurance role at Bio Space

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 around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people who are determined to make life better for people around the world.

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. The Associate Director will provide guidance on time management and priorities for direct reports and manage routine production support activities while balancing implementation of technical projects and program oversight.

This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards related to sterility assurance. It also requires the ability to multitask/prioritize and excellent written and oral communication skills, decision‑making ability, interpersonal skills, and the ability to anticipate potential problems and develop/implement solutions. The role is expected to work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plans, and quality objectives.

• 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.
• 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.

• 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’…