Senior QC Chemist (Combination Products)

United Therapeutics Corporation

3d • Onsite

About The Position

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.

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

Nice To Haves

• Working knowledge of Master Control, LabWare LIMS, SAP, TrackWise
• Working knowledge of testing required for Inhalation products including being able to independently perform testing

Responsibilities

• 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

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: Mid Level