Microbiologist

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 – Utilities, 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
• Perform 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

Qualifications

BS/MS in biology or microbiology