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Manager of Microbial Quality Control

2 months ago

Germantown, Maryland, United States Precigen, Inc Full time
Manager of Microbial Quality Control

Join the dynamic team at Precigen, Inc., a leader in biopharmaceutical innovation focused on gene and cell therapies. We are currently seeking a Manager of Microbial Quality Control to enhance our commitment to developing groundbreaking treatments for various diseases, including those in immuno-oncology and infectious diseases.

Key Responsibilities:

  • Supervise microbial testing and environmental monitoring protocols
  • Oversee the Environmental Monitoring initiative
  • Facilitate training programs on QC Microbiology and Aseptic Techniques
  • Ensure adherence to Standard Operating Procedures (SOPs) and regulatory standards
  • Investigate Out of Specification (OOS) results and environmental monitoring deviations
  • Support interactions with regulatory agencies
  • Develop and assess SOPs and validation protocols
  • Conduct laboratory investigations and manage deviations effectively

Qualifications:

  • Bachelor's degree with over 8 years of relevant experience or a Master's degree with at least 6 years in Microbiology or a related field
  • Proven experience in Environmental Monitoring, Aseptic Process Validation, and QC laboratory management
  • Comprehensive understanding of aseptic techniques, sterile gowning procedures, and cleanroom operations

Essential Skills:

  • Strong negotiation and collaboration abilities
  • Capability to develop and mentor team members
  • Exceptional communication skills
  • Flexibility to adapt to changing priorities in a fast-paced environment