QC Microbiologist

QC Microbiologist I

United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant.

The QC Microbiologist I will ensure contamination control of manufacturing facilities at RTP by performing environmental and water sampling and testing per USP and EP requirements where applicable. The QC Microbiologist I will ensure the timely and accurate testing of materials while maintaining and ensuring quality and compliance so as to meet the demands of production and other departments. Support of all manufacturing operations; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing. Perform environmental, water, and other utility sampling procedures. Perform in-house microbiological assays. Evaluate microbiological results including microbial identification, as needed. Prepare timely analytical lab reports or summaries as required. Perform environmental and utility out of specification (OOS) investigations as needed. Operate the Autoclave to ensure a supply of sterile testing materials. Ensure the supply of laboratory testing materials is readily available. Schedule, and coordinate shipping of samples for required testing to contract laboratories. Troubleshoot instrument problems and work with the lab manager and equipment manufacturer's technical services to resolve issues in a timely fashion. Perform instrument maintenance and calibration verification/standardization as required by following company SOPs.

Minimum Requirements: Working knowledge and understanding of cGMPs, USP, EP and other regulatory requirements with respect to microbiology activities. Proficiency in viable and non-viable environmental monitoring of manufacturing suites; gram staining, sub-culturing of microbial isolates, bioburden testing, gowning, aseptic technique. Ability to work as part of a team and also independently with minimal to no supervision. Computer application skills required with expertise in Microsoft office.

Preferred Requirements: Bachelor's Degree in microbiology, biology, or biochemistry or other related discipline. 2+ years of relevant experience in a microbiology laboratory and with aseptic processing is preferred. Familiarity with Trackwise, MasterControl and LIMS Pharmaceutical GMP experience.

Job Location: United Therapeutics requires this candidate to be working in-person from our Research Triangle Park, NC facility 100% of the time.