Project Engineer, Strategic Development (Biotech)

Location: Durham, North Carolina, United States. Hybrid schedule with 3 days in the office and the option to work 2 days from home each week; in-office requirements may change based on business needs.

Company

hirify.global develops pharmaceutical therapies for rare, life-threatening diseases and technologies intended to expand the availability of transplantable organs.

What you will do

• Support project management across strategic development programs involving drug products, devices, and combination products.
• Track project timelines, deliverables, milestones, budgets, and resources using tools such as Smartsheet.
• Coordinate communication between Manufacturing, Analytical, Quality, Regulatory Affairs, Clinical Operations, Marketing, and other functions.
• Support program execution from early development through clinical and regulatory milestones, including IND through NDA activities.
• Manage clinical trial material forecasting, manufacturing, packaging, labeling, distribution, and supply chain coordination.
• Coordinate vendors, outsourcing activities, purchase orders, change controls, regulatory documentation, study files, processes, procedures, pharmacy manuals, and SOPs.

Requirements

• Bachelor’s degree in Engineering or an equivalent scientific discipline.
• Project management experience.
• Ability to prioritize, organize, and manage multiple projects simultaneously.
• Experience or knowledge related to clinical trials, drug development, clinical supply, packaging, labeling, or distribution is relevant to the role.
• Excellent oral and written communication and the ability to adapt to different personalities and conflicting priorities.

Nice to have

• Master’s degree in Engineering.
• 2+ years of relevant industry experience.
• 2+ years of experience in pharmaceutical or biotech operations.
• Working knowledge of clinical trials and the drug development process.
• Familiarity with clinical trial packaging, labeling, or distribution.

Culture & Benefits

• Mission-driven work focused on unmet medical needs and patient outcomes.
• Medical, dental, vision, and prescription coverage for eligible employees.
• Wellness resources, 401(k), and employee stock purchase plan.
• Paid time off, paid parental leave, and disability benefits.
• Work environment emphasizing enthusiasm, creativity, persistence, and unconventional thinking.