QC Microbiologist I/II - Combination Products

QC Microbiologist I/II (Combination Products)

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.

We are looking to be part of a brand new QC Microbiology team supporting all of our combination product programs. The QC Microbiologist I/II (Combination Products) will ensure contamination control of manufacturing facilities by performing environmental and water sampling and testing per USP, EP, and JP requirements where applicable. The QC Microbiologist I/II will perform raw material and finished product testing per compendial methods. 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 manufacturing operations, including process validation, environmental monitoring, and sampling and testing of utility systems with general oversight from management. Perform bioburden, conductivity, and TOC testing of water as needed. Perform environmental monitoring of the facility as needed. Perform raw material, finished product, stability testing as needed. Evaluate microbiological results, including microbial identification, as needed. Operate the autoclave to ensure a supply of sterile testing materials. Maintain availability of laboratory testing materials. Schedule and coordinate shipment of samples to contract laboratories for required testing. Troubleshoot instrument issues and collaborate with the lab manager and equipment technical services to resolve issues in a timely manner. Perform instrument maintenance and calibration verification or standardization by following company SOPs. Perform all other duties as required.

Minimum Requirements

QC Microbiologist I: Bachelor's Degree in Microbiology, Biology, or Biochemistry or other related discipline. 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 supervision. Proficient with computer application skills with expertise in Microsoft office.

QC Microbiologist II: Bachelor's Degree in Microbiology, Biology, or Biochemistry or other related discipline. 2+ years of experience in a cGMP pharmaceutical microbiology laboratory. Working knowledge and understanding of cGMPs, USP, and other regulatory requirements. Proficient in viable and non-viable environmental monitoring of aseptic processes; gram staining; sub-culturing of microbial isolates; bacterial endotoxin testing; bioburden testing by membrane filtration; gowning; aseptic technique. Ability to work as part of a team and also independently with minimal to no supervision. Proficient with computer application skills with expertise in Microsoft Office (Word and Excel).

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.