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Manager of Microbial Quality Assurance

2 months ago


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

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

Key Responsibilities:

  • Supervise microbial testing procedures and environmental assessments
  • Oversee the Environmental Monitoring program to ensure compliance
  • Facilitate training initiatives on QC Microbiology and Aseptic Techniques
  • Guarantee adherence to Standard Operating Procedures (SOPs) and regulatory standards
  • Conduct investigations for Out of Specification (OOS) results and environmental monitoring deviations
  • Support interactions with regulatory agencies
  • Develop, review, and refine SOPs and validation documentation
  • Manage laboratory investigations and address 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
  • In-depth understanding of aseptic techniques, sterile gowning procedures, and cleanroom operations

Essential Skills:

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