Sufficient scientific training and competence to perform basic complexity Flow Cytometry and/or Cell Based Assays according to, and in compliance with, current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). As part of standard work, completes assigned Test Methods and other required documentation and general laboratory duties according to relevant cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. The ideal candidate will have basic flow cytometry theory and/or instrumentation and complete site training in flow cytometry assays using 1-4 colors. Experience in mammalian cell culture is desirable but not a requirement.
• Conducts basic Flow Cytometry and/or Cell Based Assay and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs. May also perform assays at R&D level in collaboration with Technical Reviewer, as assigned by Management.
• Frequently performs assays that are STAT and requires schedule flexibility and rapid completion for in support of in-process testing and/or rapid release Cell Therapy products.
• Accurately completes Test Methods and other required documentation according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
• Approximately 80% of work time will be spent in the laboratory.
• Performs work associated with BSL-2 materials (i.e. human cells).
• Follows all general and laboratory SOPs.
• As needed and directed, initiates Laboratory Investigations, Deviations and/or Non-Conforming events.
• Performs analysis of results and reports data to Technical Reviewer or supervisor.
• Communicates with supervisor and other colleagues regarding daily lab activities.
• Checks lab for expired chemicals and disposes of properly.
• Performs routine laboratory maintenance and keeps records of maintenance according to SOPs.
• Performs routine equipment cleaning (i.e. water baths) and keeps records according to guidelines and SOPs.
• Orders reagents and consumables as required.
• Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.)
• Correctly analyzes scientific data with accuracy and precision.
• Performs daily work activities with minimal supervision.
• Bachelor’s degree with major in Biological Sciences or other science-related major and 0-1 years of relevant experience.
• Candidate may have completed site specific training program in flow cytometry.
• Basic or working knowledge of flow cytometry theory and/or instrumentation and experience in flow cytometry assays using 1-4 colors.
• Ability to use advanced laboratory equipment, such as, but not limited to; Flow Cytometers, Plate Readers, Automated cell counters, etc.
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