QC Chemist I/II (combination Products)

QC Chemist I/II (Combination Products)

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 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.

Minimum 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.

Job Location

This role is located 100% onsite in RTP, NC.