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The job details are as follows: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 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
Minimum Requirements
- Bachelor's degree in Engineering or equivalent scientific discipline
- Project Management experience
- Ability to prioritize, organize and manage multiple projects simultaneously
Preferred Qualifications
- 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
Job Location
This 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.
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Eligible 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-amenities
