Microbiologist

· 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

· 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