Senior QC Microbiologist - Combination Products

Senior Qc Microbiologist (Combination Products)

United Therapeutics 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. 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. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). 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 believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

You're looking to be part of a brand new QC Microbiology team supporting all of our combination product programs. The Senior QC Microbiologist (Combination Products) maintains Quality Control microbiological systems for manufacturing facilities including air, water, and product testing per USP, EP and JP requirements where applicable. The Senior QC Microbiologist ensures the highest standards of quality and compliance within the QC microbiology laboratories. The Senior QC Microbiologist ensures timely and accurate testing, review, and release of materials, while maintaining rigorous quality and compliance standards to support production and R&D objectives. Independently support manufacturing operations, including process validation, environmental monitoring, and sampling and testing of utility systems. Perform microbiological testing on air, water, environmental, raw material, and finished product samples per UT SOPs and test methods. Plan, prepare, and execute method validation protocols as required per USP, EP, and JP requirements. Assist with establishing environmental and USP water system monitoring programs. Lead investigations involving microbiology out-of-specification results. Perform the procurement and qualification of new equipment. Maintain and lead the laboratory 5S and inventory program, ensuring supplies are available and supporting budget forecasting. Troubleshoot instrument problems and work with the lab manager and equipment technical services to resolve issues in a timely fashion. Perform instrument maintenance and calibration verification or standardization as required. Prepare, edit, and review SOPs and testing protocols. Train and mentor new employees and perform peer reviews of documentation.

Minimum Requirements:

• Bachelor's Degree in a scientific field, preferably microbiology or biology
• 5+ years of relevant experience in a microbiology laboratory
• Working knowledge of FDA, ICH, USP, EP and JP requirements with respect to microbiological activities
• Working knowledge of word processing, spreadsheets and email software
• Detail oriented, self-motivated, organized with the ability to prioritize work

Preferred Qualifications:

• 3+ years of experience in pharmaceutical and GMP
• Working knowledge of LIMS, TrackWise, RAM, and MasterControl

Job Location: United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time.