Microbiological Expert Leader

2 days ago


Pleasant Prairie, Wisconsin, United States BioSpace, Inc. Full time
Sterility Assurance Expert Leader Opportunity

We are seeking a highly experienced Sterility Assurance Expert Leader to join our team at BioSpace, Inc. This is a unique opportunity to leverage your expertise in sterility assurance and microbiology to drive innovation and improvement across our parenteral manufacturing sites.

Main Responsibilities
  • Leverage your expertise to develop approaches and drive harmonization projects across the parenteral network for sterility assurance and microbiological topics.
  • Collaborate with site and cross-functional SMEs to ensure control strategies are robust, consistent with regulatory and compliance expectations.
  • Assume leadership role within the Quality organization for a specific topic area within Sterility Assurance, including harmonization and facilitation of knowledge across the network.
Essential Qualifications
  • Bachelor's Degree required; Master's or Ph.D. in a biological science preferred.
  • 10+ years' experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
  • Strong written and oral communication skills, with proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities.
  • Understanding of cGMPs, policies, procedures, and guidelines relating to sterility assurance.
Estimated Salary Range: $130,000 - $190,000 per year

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