QC Chemist I/II (Combination Products)

United Therapeutics • Rtp, NC

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 QC Chemist I/II (Combination Products) will perform analytical testing of raw materials, finished product and stability samples for inhalation products under general supervision. Perform routine analytical testing on inhalation finished product and stability samples with supervision in accordance with company test methods and SOPs Execute analytical testing on raw material samples per SOPs and applicable USP requirements with supervision Prepare solvent mixture, buffers, and reagents required to support analytical testing Process and analyze analytical data, compare results to test specification, and accurately document results in lab reports Learn to identify and troubleshoot basic instrument issues and collaborate with the supervisor, laboratory chemists, and equipment manufacturer technical services to support resolution Follow company SOPs and cGMP requirements in the performance of all responsibilities Participate in training activities to build proficiency in QC systems, inhalation product requirements, and analytical techniques Perform all other duties as assigned

Requirements

• QC Chemist I
• Bachelor’s Degree in chemistry or related scientific field
• 1+ years of relevant experience in a pharmaceutical quality control or analytical laboratory and 1+ years of experience in chromatography and other analytical techniques
• Working knowledge of FDA, ICH, and USP requirements with respect to analytical activities
• Working knowledge of word processing, spreadsheets and email software
• Ability to communicate effectively, written and verbally, with colleagues, management, and cross‑functional partners, and to interact with regulatory agencies as needed
• Detail oriented, self motivated, and organized with the ability to prioritize work
• Ability to work independently and collaboratively within a multi‑functional team environment while managing high workloads, competing priorities, stressful situations, and deadlines
• QC Chemist II
• Bachelor’s Degree in chemistry or related scientific field
• 2+ years of relevant experience in a pharmaceutical quality control or analytical laboratory
• 2+ years of experience in chromatography and other analytical techniques
• Strong knowledge of FDA, ICH, and USP requirements with respect to analytical activities
• Working knowledge of waters empower software
• Demonstrated knowledge and application of Good Manufacturing Practices (GMPs)
• Detail oriented, self-motivated, and organized with the ability to prioritize work
• Ability to work independently and collaboratively within a multi‑functional team environment while managing high workloads, competing priorities, stressful situations, and deadlines
• Ability to communicate effectively in written and verbal formats with colleagues, management, and cross‑functional partners, and to interact with regulatory agencies as required
• Working knowledge of word processing, spreadsheets, and email software

Nice To Haves

• QC Chemist I
• 1+ years of experience testing inhalation drug products including performance testing, spray testing, and chemistry testing
• Working knowledge of chromatography and other analytical techniques
• Working knowledge of waters empower software
• QC Chemist II
• 2+ years of experience testing inhalation drug products including performance testing, spray testing, and chemistry testing

Responsibilities

• Perform analytical testing of raw materials, finished product and stability samples for inhalation products under general supervision.
• Perform routine analytical testing on inhalation finished product and stability samples with supervision in accordance with company test methods and SOPs
• Execute analytical testing on raw material samples per SOPs and applicable USP requirements with supervision
• Prepare solvent mixture, buffers, and reagents required to support analytical testing
• Process and analyze analytical data, compare results to test specification, and accurately document results in lab reports
• Learn to identify and troubleshoot basic instrument issues and collaborate with the supervisor, laboratory chemists, and equipment manufacturer technical services to support resolution
• Follow company SOPs and cGMP requirements in the performance of all responsibilities
• Participate in training activities to build proficiency in QC systems, inhalation product requirements, and analytical techniques
• Perform all 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.

What This Job Offers

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