About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As a QC Microbiology Senior Associate, you will report to the Director QC Microbiology, and perform microbial testing of product and environmental monitoring of controlled areas within the Manufacturing facility at the Bothell site.

What you’ll do

• Conduct Environmental Monitoring the production facility
• Perform personnel monitoring to support Aseptic Gowning Qualification
• Incubate and enumerate colony growth and subculture organisms
• Coordinate and manage sample shipments to approved external contract laboratories for microbiological testing, including bacterial or fungal identification
• Review and report data results from external contract labs
• Perform data entry into approved repository
• Perform Microbiological and Environmental Monitoring trending and author reports as per schedule
• Manage bacterial growth media and plate inventories, testing materials, standards, components and consumables to ensure testing execution to planned schedules
• Execute bioburden enumeration assays and endotoxin measurement assays
• Accurately complete documentation and report results, including any potential excursions and non-conforming results to departmental management in a timely manner
• Collaborate with area owners to investigate environmental excursions, and implement corrective actions
• Maintain equipment and instruments and coordinate preventive maintenance and calibrations
• Execute microbiological method qualifications and verifications protocols
• Maintain the QC lab including periodic cleaning of incubators, biosafety cabinets, cold storage chambers, and the lab
• Train personnel in and qualify personnel for aseptic gowning
• Adhere to and promote laboratory health and safety requirements

What we’re looking for

• Familiar with the US, EMA, and ICH regulations and guidance documents including aseptic guidance such as Annex 1
• Good working knowledge of microbiological assays, pharmaceutical microbiology, aseptic technique and performing work in biosafety cabinets or laminar flow hoods
• Experience with aseptic gowning and cleanroom operation activities
• Experience in contamination control strategies
• Good working knowledge of aseptic processing
• Experience with GMP Quality/Compliance systems
• Collaboration skills
• BA or BS degree in Microbiology, life science or biochemistry
• 1-2 years’ experience in the pharmaceutical or biotechnology industry in a Microbiology, Quality or Compliance function

What will separate you from the crowd

• Performing cleanroom work in sterile gowning
• Experience with writing SOPs, change controls and lab investigation reports
• Experience with facility qualification activities

What you should know 

• There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing
• The base pay range for this position at commencement of employment is expected to be between $70,000 to $85,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience