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We are looking for an enthusiastic Microbiology Analyst to support the cGMP Quality Control (QC) labs. You will be responsible for performing microbiological testing and other analytical testing to support AbCellera's state-of-art biologics drug substance clinical manufacturing facility. Additionally, you will perform supportive activities for general lab readiness and work closely with the QC Lab Manager.
Job Responsibility:
Providing microbial support for aseptic product manufacturing in a cGMP regulated environment
Performing site support activities such as environmental monitoring, compressed gas and water system sampling within the graded manufacturing area
Planning, scheduling, and coordinating microbiological sampling and testing activities to support manufacturing operations, including routine monitoring, batch-related testing, and time-critical samples, ensuring alignment with production schedules and testing timelines
Carrying out a variety of routine microbiological techniques on utilities including but not limited to bioburden, endotoxin, TOC, conductivity and growth promotion testing on incoming microbial media
Responsible for micro release testing on raw materials, in-process drug substance and final product samples
Evaluating and reviewing test results for conformance to appropriate specifications and highlighting any suspect results to the QC Lab Manager
Participating in identification, investigation (deviations/out of specifications) and resolution of problems in the microbiology lab
Authoring method verification protocols, SOPs, WIs and TMs based on industry standard compendial methods
Requirements:
5+ years of QC experience in addition to a Bachelor’s degree
Master’s degree in a relevant scientific discipline and 3+ years of QC experience
Strong knowledge and experience in Good Manufacturing Practices (GMPs), QC microbiological testing and method qualification requirements
Experience with using Milliflex Oasis, Charles River Endosafe nexgen-MCS, LIMS, as well as basic benchtop techniques such as Gram staining, plate reading, vacuum filtration and LAL gel-clot
Excellent interpersonal skills, ability to work independently and in a team environment, detail oriented, organized and methodical in execution of tasks
Ability to problem solve with sound analytical thinking
What we offer:
Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections