Supervisor, Quality Control - RMOMAL

Supervisor, Quality Control - RMOMAL page is loaded## Supervisor, Quality Control - RMOMALremote type:
On-Site locations:
RTP, NCtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R04646

California, US residents .
** 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
** You want to contribute to being the first QC hire at a greenfield site and are excited to spend plenty of the time on the bench while also continually working on process improvement and laying the foundation for future growth. You'll be supporting first of their kind regenerative organ products and will be uniquely challenged to apply your QA expertise in a brand new field.

The Supervisor of Quality Control (QC) ensures timely and accurate testing of raw materials, in-process samples, drug substances, and drug products while maintaining strict compliance with cGMP regulations and United Therapeutics (UT) quality standards. This position ensures timely and accurate analysis of raw materials, in-process samples, drug substances, and drug products in compliance with cGMP and company quality standards. The Supervisor schedules and prioritizes laboratory work, reviews data for accuracy and compliance, supports investigations and CAPA activities, and serves as a key point of contact for routine testing status with internal stakeholders.

In addition to traditional wet chemistry methods, this individual will have experience performing cell-based assays and advanced analytical techniques. This role also coordinates testing performed by external contract laboratories, manages data review from these partners, and contributes to method transfers, equipment qualifications, and continuous improvement initiatives, ensuring operational excellence and regulatory readiness within the QC laboratory. As the organization grows, this position will assume supervisory responsibilities for a small team, fostering a culture of quality and continuous improvement.
* Supervise QC operations for assigned testing (raw materials, in‑process, drug substances, drug products) in accordance with cGMP and UT standards. May support limited product development (R&D) and contract laboratory testing as assigned.
* Coordinate and prioritize day-to-day laboratory activities, including routine and ad-hoc testing, method transfers, equipment qualification, and calibration/maintenance
* Perform hands-on QC testing of raw materials, in-process samples, drug substances, and drug products using wet chemistry and cell-based methods in compliance with cGMP and company standards
* Coordinate testing activities with external contract laboratories, including sample shipment, method transfers, data review, and ensuring compliance with company standards and regulatory requirements
* Conduct and/or provide supervisory oversight of routine OOT/OOS/deviation investigations and CAPA activities related to the laboratory; escalate complex/major events to QC Management and collaborate on resolution
* Review and approve routine analytical chemistry data packages generated by internal teams and external testing organizations, confirming conformance to specifications and cGMP requirements
* Serve as primary point of contact for routine testing status in manufacturing, project, and product team meetings; escalate non‑routine issues to QC Management
* Draft and review (and approve as delegated) protocols, summary reports, and SOPs for testing, validation, method transfers, equipment qualifications, equipment operation, and analytical test methods; participate in supporting testing as needed
* Support…