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Manager/Senior Manager, QC Microbiology

EPM Scientific
Feasterville, Pennsylvania, US
Closing date
May 16, 2024

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
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:
  • Bachelor's 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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