Microbiologist

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·We are seeking a highly motivated QC Microbiologist who is interested in joining our fast-paced, dynamic QC environment to perform microbiological test methods in support of Facility Utilities Monitoring and Environmental Monitoring Program in support of the GMP manufacturing facility of a cell therapy product including sampling of raw material and release testing.

Duties & Responsibilities:

·Performing lab tests in the areas of bacteriology, mycology, mycobacteriology

·Performs environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers

·Performs routine and non-routine microbiological testing such as water bioburden and media growth promotion; Gram staining and microbial identifications

·Performs enumeration and characterization of microorganisms recovered from samples

·Participate in aseptic processing in a clean room environment

·Perform growth promotion

·Identifies bacteria and susceptibilities, molds, yeast, parasites, and other related organisms

·Perform Microbiological test methods for cell therapy product, raw material and release testing

·Perform protocol driven studies for bioburden, endotoxin, , EM, Raw Materials -ID, etc.

·Generating data to support site manufacturing and/or complaint investigations and resolving project-related questions

·Manage variable sample influx by potentially adjusting daily schedule

·Communicate expected sample test times and results with QC Lab Assistants

Minimum Requirements:

·B.S. in Biology/Microbiology, or related sciences with 3-5 years of related experience.

·Previous working experience in a QC laboratory GMP manufacturing facility highly desirable

·Strong time management and organization skills are required

·Knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP)

·Aseptic technique or cleanroom experience desired

·Organism identification experience a plus

·The ability to work off-shift hours, based on business needs, is required

·Able to work independently with minimum supervision

·Good accurate and clear documentation skills is required

Qualifications

·B.S. in Biology/Microbiology, or related sciences with 3-5 years of related experience.

·Previous working experience in a QC laboratory GMP manufacturing facility highly desirabl