QC Microbiologist I/II - Combination Products

United Therapeutics Corporation

20h • Onsite

About The Position

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 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 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

Requirements

• 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
• 2+ years of experience in a cGMP pharmaceutical microbiology laboratory
• 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

Nice To Haves

• 1+ years of relevant experience in a microbiology laboratory and with aseptic processing
• Familiarity with Trackwise, MasterControl and LIMS
• Pharmaceutical GMP experience
• Familiarity with Trackwise, MasterControl, SAP, LIMS

Responsibilities

• 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

Benefits

• 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.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level