Supervisor, Quality Control - RMOMAL

California, US residents. 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 develop treatments for rare, deadly diseases. Founded in 1996, the company now holds six FDA‑approved therapies that treat pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, and neuroblastoma. The near‑term pipeline focuses on additional therapies for PAH and pulmonary fibrosis. Our mission is to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, aiming to 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 time on the bench while also continually working on process improvement and laying the foundation for future growth. You will support first‑of‐their‑kind regenerative organ products and apply your QA expertise in a brand new field. Responsibilities Supervise QC operations for assigned testing (raw materials, in‑process, drug substances, drug products) in accordance with cGMP and US standards. May support limited product development 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 regulations 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 provide supervisory oversight of routine OOT/OOS/deviation investigations and CAPA activities related to the laboratory; 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; escalates 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; support 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 and compendial changes within the QC analytical 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. 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; escalates 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 that this candidate be on‑site at our Durham, North Carolina location 100% of the time. 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, and paid parental leave benefits. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. #J-18808-Ljbffr