Job Description

We are seeking a highly motivated individual to join us as a QC Microbiologist in our new commercial cell therapy production center located in Frederick MD. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This position provides Quality Control microbiological testing for commercial manufactured product, responsible for product testing, utility testing and environmental monitoring.

Responsibilities:

Performs environmental and/or utility monitoring and sampling as a primary function.

Performs routine and non-routine inspection of media fill samples (AOQ/APV), collection and/or testing of media, final product, validation-related, and critical utility samples according to SOPs.

Receives, quarantines, and stores purchased microbiological media pending laboratory release.

Monitors bio hazardous waste and coordinates its removal with qualified safety personnel.

Participates in validation and commercial/developmental manufacturing activities.

Reviews and issues Environmental Notifications based on raw data, and validated electronic data acquisition systems.

Represents QC for area of specialization in site meetings.

Supports testing of solid oral dosage, packaging component testing, raw material and sterile product testing.

Troubleshoots standard instrumentation/test methods.

Performs activities in support of final product release testing (e.g. tests applicable for endotoxin, sterility, and particle isolation) and raw material testing (e.g. media growth promotion) where required.

Performs activities in support of environmental monitoring including surface viable air, non-viable air and personnel monitoring.

Performs activities in support of bioburden testing of water and product; and viable/non-viable particles, moisture testing of compressed gases/air