QC Analyst 2, Microbiology

This position is responsible for providing support to the Quality Control Microbiology Department at GeneFab, with a primary focus on maintaining the Environmental Monitoring Program for cleanrooms used in cGMP manufacturing operations.

Responsibilities

• Perform Environmental Monitoring of ISO 5, 7 and 8 Cleanroom which entails sampling and data review of viable and non-viable air particulates in GMP Manufacturing facility
• Performs Environmental and Personnel Monitoring during critical manufacturing processing steps
• Conduct bioburden testing on in-process and release drug product samples
• Conduct lot release testing (LAL, Mycoplasma, Sterility, Osmo, pH)
• Lead and perform microbiology method transfer and validation
• Lead laboratory and deviation investigations for environmental monitoring excursions and supporting QC equipment
• Author and revise microbiology SOPs, protocols and reports
• Compile and trend Environmental data for reporting purposes
• Collaborate with Manufacturing, Operations, Facilities, Supply Chain and QA to coordinate routine EM, changeover EM, and monitoring to support campaigns
  
  
  

Qualifications

• Bachelor’s degree in science field with 3-5 years of experience
• Bachelor’s degree in science field is preferred
• Experience in GMP preferred
• Experience in Quality Control required
• Experience with Environmental Monitoring and testing (Bioburden, LAL, pH, etc.) is required
• Experience with BacT and BioFire a plus
  
  
  

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.