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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
- Perform complex analytical testing on Inhalation finished product samples, and stability samples with limited supervision per UT test methods and SOPs
- Perform complex analytical testing per UT SOPs on raw material samples according to USP, EP and JP where applicable with limited supervision
- Prepare and update documents including SOPs, test methods, specifications, protocols, and technical reports
- Ensure current compliance with compendial requirements
- Check quality control laboratory documentation to include laboratory notebooks, LIMS, SOPs, and Protocols
- Troubleshoot laboratory equipment
- Engage in departmental training not only for self, but also provide for existing employees and new hires. This can include delivery of hands-on training for new hires and/or retraining for new and existing employees.
- Execute method transfer, method validation, and method verification protocols as required
- Perform other duties as assigned
Minimum Requirements
- Bachelor’s Degree in chemistry or related scientific field
- 5+ years of experience in a pharmaceutical quality control or analytical laboratory, including being able to perform complex analytical testing on Inhalation finished product samples, and stability samples with limited supervision
- Technical writing expertise and good oral communication skills
- Working knowledge of word processing, spreadsheets and email software
- Working knowledge of Waters Empower Software
- Working knowledge of FDA cGMP requirements and USP requirements for testing of pharmaceutical drug substances and products
Preferred Qualifications
- Working knowledge of Master Control, LabWare LIMS, SAP, TrackWise
- Working knowledge of testing required for Inhalation products including being able to independently perform testing
Job Location
This role is located 100% onsite in RTP, NC.
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.
Learn more about this Employer on their Career Site
