Project Engineer, Strategic Development

United Therapeutics Corporation; North Carolina; Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical/dental/vision

401k and ESPP

Paid time off

Parental leave

Job summary

United Therapeutics Corporation in Durham, NC is seeking a Project Engineer to support strategic development programs spanning drug formulation, device development, and combination product platforms.

The role emphasizes technical engineering support, CMC activities, clinical supply management, and launch planning, with hybrid work options and engagement across regulatory and clinical groups.

Qualifications

• Bachelor’s degree in Engineering or equivalent required.
• Project management experience required.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Support multiple strategic development programs across drug, device, and combination product platforms.
• Manage and track project timelines, deliverables, and milestones.
• Coordinate cross-functional communication between Manufacturing, Analytical, Quality, Regulatory, and Clinical Operations.
• Forecast, track, and manage Clinical Trial Material manufacturing and supply chain.

Skills

Project management

Prioritization

Communication

Cross-functional collaboration

Engineering knowledge

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

Smartsheet

Job description

California, US residents .The job details are as follows:Who We AreWe 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.How you’ll contributeThe Project Engineer will support a portfolio of Strategic Development programs spanning drug formulation, device development, and combination product platforms. The role is heavily focused on technical engineering support, technical CMC activities, clinical supply management, project management, and launch planning. Additional responsibilities will include budget management, regulatory strategy, and supply chain coordination.Support project management activities across multiple strategic development programs, including drug product and combination product initiativesManage and track project timelines, deliverables, and milestones using tools such as SmartsheetCoordinate cross-functional communication between Manufacturing, Analytical, Quality, Regulatory Affairs, and Clinical Operations.Assist with program execution from early development through clinical and regulatory milestones (IND through NDA)Forecast, track, and manage Clinical Trial Material manufacturing and supply chain including raw materials coordination, manufacturing operations packaging and labelingMaintain oversight of CTM study files (hard copy & electronic, as appropriate) to ensure they are kept current, accurate, and complete in the TMFManage outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for outsourced projectsSupport vendor communication and coordination, including purchase order (PO) processingAssist with budget tracking and resource planning across programsContribute to regulatory documentation review and clinical supply coordinationInitiate and own change controls as needed for various Strategic Development programsCoordinate with Regulatory, Marketing, and Clinical groups to help develop final labeling materials for both clinical and commercial productAssist in the development of processes, procedures, and guidelines to meet short and long-term goals for clinical supplies, including pharmacy manual and SOP creation/maintenance when requiredPerform other duties as assignedMinimum RequirementsBachelor’s degree in Engineering or equivalent scientific disciplineProject Management experienceAbility to prioritize, organize and manage multiple projects simultaneouslyPreferred QualificationsMaster’s degree in Engineering2+ years of relevant industry experience2+ year of experience in pharmaceutical/biotech operationsWorking knowledge of clinical trials and the drug development processFamiliarity with clinical trial packaging/labeling and/or distributionInterpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals; the ability to handle many conflicting priorities is critical to build and maintain credibility and respect across the many different constituents in the supply chainExcellent oral and written communication Job LocationThis position will be located at our Durham, NC office with a hybrid schedule of 3 days in office and the option to work 2 days each week from home. In office requirements could change based on business needs.At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.#LI-DNIEligible 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 & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenitiesUnited Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.