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Senior QC Chemist (Combination Products)

United Therapeutics Corporation
Posted 3 days ago, valid for 18 days
Location

Durham, NC 27702, US

Salary

Competitive

Contract type

Full Time

Paid Time Off

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Sonic Summary

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  • United Therapeutics is seeking a Senior QC Chemist with a Bachelor’s Degree in chemistry or a related field and at least 5 years of experience in a pharmaceutical quality control or analytical laboratory.
  • This role involves performing complex analytical testing on inhalation products, raw materials, and stability samples, as well as technical writing and method development.
  • Candidates should have expertise in technical writing, good oral communication skills, and knowledge of FDA cGMP and USP requirements for testing pharmaceutical products.
  • The position is located 100% onsite in RTP, NC, and eligible employees can participate in a comprehensive benefits suite including medical, dental, and retirement plans.
  • Salary information is not provided in the job description.

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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

If you’re a QC chemist who enjoys being hands‑on at the bench, thinking critically about data, and seeing your work directly support patient‑ready therapies, this role offers exactly that—and more. The Senior QC Chemist (Combination Products) will perform analytical testing of raw materials, finished product and stability samples for various Inhalation products, and Active Pharmaceutical Ingredient (API) samples. This role also includes technical writing (SOPs, test methods, specifications, protocols, and reports). Additional responsibilities include method transfer, method development, and method validation.
  • 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.




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