Sterility Assurance Director

1 week ago

Somerville, New Jersey, United States Lilly Full time
About the Role

Lilly is seeking a highly skilled Sterility Assurance Director to join our team. As a key member of our Parenteral Sterility Assurance team, you will be responsible for providing oversight and driving harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network.

Key Responsibilities
  • Assess differences in current sterility assurance programs across sites and drive harmonization
  • Work closely with site and multi-functional SMEs to drive cohesion and ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved
  • Represent TS/MS on network Science Lead Team and other appropriate governance forums to ensure Sterility Assurance programs and similar topics are frequently presented to network teams
  • Provide mentoring leadership to site SMEs to help build capability, particularly at newer sites or where deep technical expertise is lacking
  • Provide technical support to new sites/filling lines during design and start-up activities to ensure sterility assurance programs and process/product requirements are supported
  • Benchmark industry trends and emerging regulatory guidance/requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups
Requirements
  • BS Degree required; MS/PhD in a biological science preferred
  • 10+ years' experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles preferred
  • Deep technical understanding of sterility assurance from a science and compliance perspective
  • 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
About Lilly

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We are committed to delivering innovative medicines to patients around the world and are entering an exciting period of growth. 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.

What We Offer
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A comprehensive benefits package
  • A commitment to diversity, equity, and inclusion

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