QC Microbiologist

About Us

We are 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 (Nasdaq: UTHR) seeks to develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH), we now have six FDA-approved therapies treating PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma, a rare pediatric cancer. Our near-term pipeline aims to develop additional therapies for PAH and pulmonary fibrosis (PF). To address the shortage of transplantable organs, we are working to create manufactured organs for kidneys, hearts, lungs, and livers, with the goal of eliminating transplant waiting lists and curing end-stage organ diseases.

Responsibilities

• Ensure contamination control of manufacturing facilities at RTP by performing environmental and water sampling and testing per USP and EP requirements.
• Perform timely and accurate testing of materials while maintaining quality and compliance to meet production demands.
• Support manufacturing operations, including process validation, environmental monitoring, and utility systems sampling and testing.
• Perform environmental, water, and other utility sampling procedures.
• Conduct in-house microbiological assays and evaluate results, including microbial identification as needed.
• Prepare timely analytical lab reports or summaries.
• Investigate Environmental and utility out-of-specification (OOS) results as needed.
• Operate the Autoclave to ensure a supply of sterile testing materials.
• Maintain a ready supply of laboratory testing materials.
• Schedule and coordinate shipping of samples for required testing to contract laboratories.
• Troubleshoot instrument problems and work with the lab manager and equipment manufacturers to resolve issues.
• Perform instrument maintenance and calibration verification/standardization following company SOPs.

Requirements

• Working knowledge and understanding of cGMPs, USP, EP, and other regulatory requirements related to microbiology activities.
• Proficiency in viable and non-viable environmental monitoring of manufacturing suites, including gram staining, sub-culturing of microbial isolates, bioburden testing, gowning, and aseptic technique.
• Ability to work as part of a team and independently with minimal supervision.
• Computer application skills, including expertise in Microsoft Office.

Preferred Qualifications

• Bachelor’s Degree in microbiology, biology, biochemistry, or a related discipline.
• 2+ years of relevant experience in a microbiology laboratory and with aseptic processing.
• Familiarity with Trackwise, MasterControl, and LIMS.
• Pharmaceutical GMP experience.

Location

This role requires working in-person from our Research Triangle Park, NC facility 100% of the time.

Benefits

Eligible employees may participate in the Company’s comprehensive benefits suite, including:

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off and paid parental leave.
• Disability benefits.

For additional information, visit United Therapeutics Benefits.