Associate Director - TSMS Sterility Assurance

Eli Lilly and-posted 3 months ago
$123,000 - $180,400/Yr
Full-time • Senior
Pleasant Prairie, WI
Chemical Manufacturing
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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 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. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

  • Oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing.
  • Leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing.
  • Providing guidance on time management and priorities for direct reports.
  • Managing routine production support activities while balancing implementation of technical projects and program oversight.
  • Maintaining a safe work environment, leading safety initiatives, and working safely.
  • Designing and executing technical and defendable contamination control strategies.
  • Performance management and development of staff.
  • Partnering within TS/MS and across functional disciplines to influence and implement the technical agenda.
  • Technical review and approval for site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports.
  • Defining and maintaining inspection readiness activities; interacting with regulatory agencies during inspections.
  • Networking internally and externally to understand best practices and share knowledge.
  • Maintaining metrics to measure performance against business objectives.
  • Using sterility assurance risk management to evaluate proposed manufacturing processes.
  • Ensuring site's environmental monitoring, aseptic process simulations, facility cleaning, and other sterility assurance programs are followed.
  • Providing technical guidance to the Process Team for sterility assurance programs and root cause investigations.
  • Analyzing microbial and manufacturing data using statistical principles to identify trends and opportunities for continuous improvements.
  • 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.
  • Deep technical understanding of sterility assurance from a science and compliance perspective.
  • Minimum 3 years of management or leadership experience.
  • Teamwork and interpersonal skills.
  • Independent critical decision making, complex problem solving, and prioritization skills.
  • Multi-tasking and communications skills.
  • Ability to influence diverse groups.
  • Proficiency in data analysis and attention to detail.
  • Strong written and oral communication skills.
  • Ability to mentor and develop scientists in 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.
  • Strength in scientific and practical thinking.
  • Strong capability to influence personnel and management across the organization.
  • Additional relevant experience in Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories.
  • Experience with syringe technology and isolator filling technology.
  • Eligibility to participate in a company-sponsored 401(k); pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision and prescription drug benefits.
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
  • Life insurance and death benefits.
  • Certain time off and leave of absence benefits.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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