Manager/Senior Manager, QC Microbiology

3 weeks ago


Philadelphia, United States EPM Scientific Full time

A rapidly growing biotech organization is growing out their microbiology team This is not a bench position. This position is more centered towards contamination control and method validation. See the key responsibilities below:

Sterility Assurance and Contamination Control

  • Ensure the site's compliance with sterile processing and contamination control standards, including environmental monitoring, clean-room management, and sterilization.
  • Develop and maintain strategies to control microbial contamination and cross-contamination.
  • Support the development of contamination control strategies and maintain risk assessments related to microbial contamination.

Environmental Monitoring and Utilities

  • Oversee environmental monitoring programs, including utilities and trending reports for compliance and technical accuracy.
  • Develop strategies for effective environmental monitoring and oversee site-wide testing for contamination.

Technical Writing and Communication

  • Author and revise procedures and technical documents for sterility assurance.
  • Communicate with senior management about contamination control issues.
  • Participate in continuous improvement initiatives and promote best practices for contamination control.

Microbiological Expertise

  • Ensure compliance with global standards and regulations for microbiology and sterility assurance.
  • Troubleshoot contamination issues and support related investigations.
  • Provide oversight for microbiological testing performed in-house and at contract laboratories.
  • Microbial method validations.

Key Qualifications:

  • Bachelors degree in the Microbiology, Life Science, or related field.
  • Minimum of 5 years of QC Microbiology experience in the pharma/biotech industry.
  • Experience with rapid microbial test methods: sterility, endotoxin, and/or mycoplasma
  • Experience in microbial contamination control.
  • Experience with microbiological risk assessments.
  • Experience with cell therapy products is a plus.


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