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QC Microbiologist I
- United Therapeutics (Silver Spring, MD)
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California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
Who We Are
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.
Who You Are
The QC Microbiologist I will assist in ensuring the timely and accurate testing of materials and product while maintaining and ensuring quality and compliance to meet the demands of production and other departments.
+ Assist in the support of manufacturing operations including, but not limited to, process validation, environmental monitoring, and utility systems sampling and testing
+ Perform in-house microbiological assays
+ Perform environmental, water, and other utility sampling procedures
+ Sample raw materials as needed
+ Schedule and coordinate shipping of samples for required testing to contract laboratories
+ Perform timely review and release of microbial test results as to ensure compliance with the standard operating procedure (SOPs) and ensure reported data is accurate
+ Prepare timely analytical lab reports or summaries as required
+ Assist in writing, revising, and reviewing SOPs for compliance with respective compendia, equipment operation, methods and general laboratory procedures as needed
+ Assist in training other department employees in departmental operations and SOPs as required
+ 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 following company SOPs
+ Schedule and coordinate annual preventive maintenance and/or calibration of the various microbiological instruments to ensure compliance with the calibration program, as required
+ Initiate and complete out of specifications (OOS), deviations as needed
+ Maintain and support RAM, ELPRO databases
+ Coordinate with manager and other staff members in organizing workload
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in microbiology or biology or other scientific discipline with equivalent experience/training
+ 1+ years of experience in a cGMP pharmaceutical/biotechnology microbiology laboratory
+ Ability to work as part of a team and also independently with minimal to no supervision
+ Computer application skills with expertise in Microsoft Office (Word and Excel)
Preferred Qualifications
+ 1+ years of working knowledge and understanding of cGMPs, USP, and other regulatory requirements
+ Demonstrate proficiency in the following techniques: utility monitoring including but not limited to water sampling, viable and non-viable particulate monitoring; gram staining; sub-culturing of microbial isolates; bacterial endotoxin testing; bioburden testing by membrane filtration; gowning aseptic technique
Job Location
United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location.
The salary for this position ranges from $63,000 to $80,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
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
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
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