Jobs at United Therapeutics

Leads automation and controls engineering for distributed control, manufacturing and packaging automation, and environmental monitoring systems in a regulated pharmaceutical environment. Responsibilities include PLC, HMI, network, database, and code troubleshooting; system design and implementation; project leadership; validation and change control; maintenance; standards review; and collaboration with engineering, manufacturing, IT, and validation teams.

Supports strategic development programs involving drug formulation, device and combination products, clinical supply, CMC activities, regulatory milestones, and launch planning. Manages timelines, vendors, budgets, clinical trial materials, documentation, labeling, change controls, and cross-functional coordination across Manufacturing, Quality, Regulatory, Clinical Operations, Marketing, and supply chain teams.

Manages end-to-end product complaint handling, investigations, regulatory reporting, returned goods, and quality-system workflows for drugs, devices, biologics, and combination products. Supports vendor oversight, audits, inspections, CAPAs, risk assessment, training, regulatory compliance, and process improvements. Coordinates with QA, pharmacovigilance, patients, healthcare professionals, pharmacies, and internal and external partners to ensure accurate, timely complaint resolution and reporting.

Leads global product complaint safety governance across drugs, devices, biologics, and combination products. Oversees complaint processing, regulatory reporting, SOPs, training, inspection readiness, vendor oversight, quality systems, CAPAs, and compliance with global pharmacovigilance and medical device regulations. Partners cross-functionally to improve workflows, manage risks, support audits, and maintain patient safety. Directly manages personnel and serves as the escalation point for complex complaint, safety, quality, and regulatory issues.

Oversee global pharmacovigilance partnerships, safety data exchange, ICSR case management, reconciliation, compliance, and reporting quality. Serve as an escalation point and subject matter expert for regulatory, governance, audit, and inspection-readiness issues. Lead risk-based improvements, root-cause analyses, CAPAs, procedures, training, and cross-functional initiatives supporting accurate and timely adverse-event reporting across partners, affiliates, alliances, and QPPVs.

Leads the design, configuration, implementation, and optimization of SAP S/4HANA finance and integrated enterprise processes. Partners with Finance, Supply Chain, and Procurement stakeholders across Record to Report, Source to Pay, and Order to Cash. Translates business needs into scalable solutions, manages delivery activities, coordinates testing and deployment, supports upgrades, and maintains financial master data integrity.

Manages sales and promotion of Remodulin, Orenitram, and other therapies to specialty physicians and healthcare professionals across Northern California. Builds customer relationships, develops territory business plans, analyzes sales performance, provides disease and product education, coordinates field activities, supports conferences, and ensures regulatory and administrative compliance. The role is remote but requires 80% travel for customer meetings, office visits, and national events.

Drive pharmaceutical sales for PAH and PH-ILD therapies across Austin, San Antonio, and West Texas. Build relationships with specialty physicians and healthcare professionals, educate stakeholders, manage strategic accounts, analyze sales performance, execute territory business plans, achieve sales targets, maintain product and disease expertise, and support conferences and patient programs. The role requires extensive travel and compliance with promotional and regulatory guidelines.

Supports pharmaceutical fill-finish production in a cGMP environment by operating equipment, preparing materials, monitoring processes, troubleshooting basic issues, receiving raw materials, and completing batch records and documentation. The role ensures adherence to quality, safety, and compliance standards while supporting sterile operations, inventory readiness, SOP updates, and production targets.

Manages sales of pharmaceutical therapies for pulmonary arterial hypertension and related conditions across the Inland Empire. Builds relationships with specialty physicians and healthcare professionals, provides product and disease education, analyzes sales data, develops territory business plans, coordinates field activities, maintains compliance, and attends medical conferences and patient support meetings. Requires extensive specialty pharmaceutical sales or advanced lung disease experience, cardiovascular or pulmonary expertise, a valid driver’s license, and 75–80% travel.

Lead local and regional clinical trials from start-up through close-out, overseeing timelines, budgets, vendors, quality, compliance, protocol adherence, and cross-functional delivery. Manage study communications, risks, deviations, training, investigator meetings, resources, and performance metrics. Contribute to protocols, SOPs, policies, process improvements, and clinical reports while ensuring compliance with ICH/GCP and applicable regulations.

Manage daily cash positioning, execute and record wires/ACH, support Accounts Payable, prepare cash and investment reporting, analyze fees, maintain bank accounts and controls, support SOX compliance, assist financial statement disclosures, identify automation opportunities, and support treasury system implementations.

Manages a regional territory to grow sales of Remodulin, Orenitram, and Tyvaso among cardiopulmonary healthcare providers and accounts. Responsibilities include territory planning, product education, relationship management, sales analysis, business development, compliance, expense management, conference participation, and collaboration with sales and marketing teams. The specialist also provides feedback to leadership and may mentor colleagues.

Leads process development for an iPSC-derived thymic epithelial progenitor cell process, including expansion, differentiation, scale-up, harvest, downstream processing, formulation, fill-finish, cryopreservation, and stability. Designs process characterization studies, supports technology transfer, validation, GMP readiness, and FDA submissions, and develops biomaterial-based cell delivery approaches. Collaborates with analytical and technical teams, interprets experimental data, prepares CMC documentation, maintains compliant records, and mentors junior scientists.

Manage employment compliance and immigration programs, including work authorization, I-9, E-Verify, regulatory reporting, federal contractor obligations, audits, policies, relocations, vendors, and employee mobility. Advise HR leadership on legal and regulatory risks, develop training and guidance, oversee corrective actions, and implement process improvements. Collaborate with Legal, Talent Acquisition, HR teams, leadership, outside counsel, consultants, and vendors to maintain compliance and improve employee experiences.

Leads analytical development strategy for an iPSC-derived cell therapy pipeline. Manages staff, assay and potency strategy, method development, qualification, transfer, stability studies, GMP manufacturing support, QC issue resolution, CDMO and testing-lab relationships, regulatory CMC submissions, budgets, and departmental capability planning. Requires extensive biotech or pharmaceutical experience, management expertise, hands-on cell therapy analytics, and knowledge of regulatory requirements.

Designs, develops, and maintains enterprise data architecture and ETL/ELT pipelines using Databricks and Azure Data Factory. Supports data processing operations, monitoring, troubleshooting, security controls, and performance optimization. Collaborates with analysts, data scientists, and business stakeholders to deliver analytics solutions, while providing technical guidance, reviewing consultant work, leading process improvements, and contributing to code reviews and documentation.

Lead design, build, validate and deploy AI/ML, NLP, and generative AI solutions for pharmacovigilance and biomedical research. Integrate structured and unstructured safety data, create scalable ingestion and analytics pipelines, apply ontology mapping and ML models for signal detection, triage, duplicate detection, and visualization. Ensure regulatory/GxP compliance, model governance, explainability, and deliver production-grade AI platforms supporting patient safety.

Provides executive leadership for global patient safety strategy, pharmacovigilance, benefit-risk assessment, safety surveillance, regulatory compliance, and governance across investigational and marketed pulmonary products. Oversees safety leaders and physicians, guides regulatory submissions and inspections, leads cross-functional safety decisions, supports risk management plans, and drives innovation using AI and advanced analytics. Requires an MD and extensive pharma or biopharma safety leadership experience.

Manage the GMP Supplier Quality Management program across company sites, overseeing supplier qualification, risk assessments, audits, quality agreements, performance metrics, change notifications, deviations, CAPAs, escalations, and continuous improvement. Serve as the primary quality liaison for internal teams and external suppliers, maintain vendor records and procedures, support inspections and recalls, and lead cross-functional supplier quality initiatives while ensuring FDA, cGMP, and medical device regulatory compliance.