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Manager/Sr. Manager – Microbiology and Environmental Monitoring

Description:

As a Manager/Sr. Manager of the Microbiology and Environmental Monitoring team, you will lead a dynamic group responsible for internal and external microbiology services. The incumbent will manage both the environmental monitoring of cell banking and cell therapeutics manufacturing, as well as customer-driven microbiology testing services. You will be responsible for designing and developing compendial, standard, and custom microbiology assays, as well as improving and troubleshooting existing assays. You will demonstrate leadership in a fast-paced manufacturing and testing setting, making appropriate recommendations to mitigate issues and drive improvements. You must demonstrate a strong working knowledge of regulatory expectations for environmental monitoring and routine microbiological testing.

Requirements:

  • A MS/PhD in Microbiology or related field with 3 to 5 years of experience in successfully leading manufacturing and testing services in a CRO/CMO setting is required.
  • Extensive experience with microbiology testing, including but not limited to successfully implementing and managing services for:
    • USP microbiology tests, including mammalian and bacterial product-based testing
    • Environmental monitoring, including surface, air, water, gas
    • Trending and risk management
  • Proven leadership skills are required, with previous experience successfully leading a microbiology team.
  • Experience in lean culture and process improvements, including LIMS implementation, is strongly preferred.
  • Previous CRO/CMO experience and GLP/GMP knowledge is required.
  • Ability to design and troubleshoot experiments is required.
  • Must demonstrate highly effective written and oral communication skills.
  • Must effectively assist with client and regulatory audits, as needed.