Supervisor, Quality Control - RMOMAL

Supervisor of Quality Control (QC)

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 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.

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 installation/operation/qualification (IQ/OQ/PQ) of new or transferred laboratory equipment, including drafting/reviewing protocols, executing tests, and coordinating with contract vendors under guidance from QC Management. Assist with implementation of applicable regulatory/compendial changes within the QC Analytical Chemistry laboratory; maintain current knowledge of cGMP and compendial requirements relevant to scope. Provide supervisory oversight and on-the-job training for Analytical Chemists/Analysts, including assignment of curricula and coaching; contribute input to performance feedback under the direction of QC Management. Provide routine operational metrics and recommendations to the QC Manager to maintain or improve efficiency and performance. Troubleshoot routine instrument and LIMS issues; coordinate with internal resources, and vendor technical services to resolve problems; escalate systemic or complex issues appropriately.

Minimum Requirements: Bachelor's Degree in chemistry or other scientific discipline. 5+ years of related experience in a GMP pharmaceutical laboratory. Applied knowledge of cGMP requirements and QC laboratory practices. Proficiency in wet chemistry techniques and experience with cell-based assays (e.g., potency testing, viability assays, or similar); familiarity with LIMS and cGMP documentation practices. Strong written and verbal communication skills to interact cross-functionally and with management; ability to clearly summarize testing status and quality issues. Experience managing contract laboratory relationships and reviewing external data packages. Detail-oriented, organized, and self-motivated with the ability to prioritize work in a dynamic environment; able to work independently and within a multi-functional team. Prior lead experience (e.g., coordinating daily work, mentoring junior analysts, or acting as shift lead).

Preferred Qualifications: Master's Degree. 1+ years of people management experience. Experience with method transfers, equipment qualification (IQ/OQ/PQ), and data review/approval under a delegation matrix. Familiarity with OOT/OOS/deviation investigation practices and CAPA execution in QC.

Job Location: United Therapeutics requires this candidate to be working in-person from our Research Triangle Park, NC facility when not on business travel.