QC Microbiologist

United Therapeutics•Rtp, NC

19h•Onsite

About The Position

United Therapeutics (Nasdaq: UTHR) is the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. We seek to develop treatments for rare, deadly diseases. Founded in 1996, we now have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. Our pipeline focuses on developing additional therapies for PAH and pulmonary fibrosis (PF). We are also working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, believing an unlimited supply will eliminate the transplant waiting list and cure end-stage organ diseases.

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

Nice To Haves

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

Responsibilities

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