Project Engineer, Strategic Development

United Therapeutics Corporation•RTP, NC, NC

7d•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a publicly-traded biotech company with a public benefit purpose to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. Founded in 1996, the company has six FDA-approved therapies for rare diseases and is working to create manufactured organs to address the shortage of transplantable organs. The Project Engineer will support a portfolio of Strategic Development programs, focusing on drug formulation, device development, and combination product platforms. This role involves significant technical engineering support, technical CMC activities, clinical supply management, project management, and launch planning. Additional responsibilities include budget management, regulatory strategy, and supply chain coordination.

Requirements

Bachelor’s degree in Engineering or equivalent scientific discipline
Project Management experience
Ability to prioritize, organize and manage multiple projects simultaneously

Nice To Haves

Master’s degree in Engineering
2+ years of relevant industry experience
2+ year of experience in pharmaceutical/biotech operations
Working knowledge of clinical trials and the drug development process
Familiarity with clinical trial packaging/labeling and/or distribution
Interpersonal 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 chain
Excellent oral and written communication

Responsibilities

Support project management activities across multiple strategic development programs, including drug product and combination product initiatives
Manage and track project timelines, deliverables, and milestones using tools such as Smartsheet
Coordinate 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 labeling
Maintain oversight of CTM study files (hard copy & electronic, as appropriate) to ensure they are kept current, accurate, and complete in the TMF
Manage outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for outsourced projects
Support vendor communication and coordination, including purchase order (PO) processing
Assist with budget tracking and resource planning across programs
Contribute to regulatory documentation review and clinical supply coordination
Initiate and own change controls as needed for various Strategic Development programs
Coordinate with Regulatory, Marketing, and Clinical groups to help develop final labeling materials for both clinical and commercial product
Assist 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 required
Perform other duties as assigned