Microbiologist

Following is the position details:

Title: Microbiologist - Permanent Position

Location: West Chester, PA.

Job Description:

We are seeking a highly motivated QC Microbiologist who is interested in joining our fast-paced, dynamic QC environment to perform microbiological sampling 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

·Sampling Lead – Utililities, gases, EM and Raw Materials

·Submit micro identifications to CRO

·Responsible for daily scheduling of junior analyst sampling schedule

·Manage variable sample influx by potentially adjusting daily schedule

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

·Participate in aseptic processing in a clean room environment

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

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

·Report testing results via Laboratory Inventory Management System (LIMS)

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

·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

·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

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) a plus

·Aseptic technique or cleanroom experience desired

·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