Project Engineer, Strategic Development

California, US residents .The job details are as follows:

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 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 contribute

The 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 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 TMFManage 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

Minimum Requirements Bachelor’s degree in Engineering or equivalent scientific discipline

Project Management experience

Ability to prioritize, organize and manage multiple projects simultaneously

Preferred…