United Therapeutics Corporation · 12 hours ago
Supervisor, Quality Control - RMOMAL
Triangle Area
Full-time
Onsite
Senior Level
5+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing pharmaceutical therapies and technologies for transplantable organs. The Supervisor of Quality Control (QC) ensures timely and accurate testing of raw materials, in-process samples, and drug products while maintaining compliance with cGMP regulations and company quality standards.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
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
Qualification
Required
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
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
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Martine Rothblatt
Founder and CEO
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2026-01-15
2026-01-09
Company data provided by crunchbase