Principal External Manufacturing Specialist (Advanced Therapies)

Location: East Greenbush, New York, United States; onsite, Monday-Friday, 8:00am-4:30pm. Travel up to 25%.

Salary: $92,200-$150,600 annually.

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Serve as the operational contact for contract manufacturing organizations and partner sites.
• Coordinate batch scheduling, material supply, shipments, cycle-time tracking, documentation, and technical support for external manufacturing activities.
• Act as a liaison between Quality Control, Quality Assurance, Supply Chain, Operations, Logistics, and external manufacturing partners.
• Lead continuous improvement, system implementation, and strategy development initiatives.
• Support external manufacturing and shipping investigations, contract negotiations, and long-term partner strategy.
• Monitor cGMP compliance, support tech transfer and development work, and review master and executed batch records.

Requirements

• BS/BA in a scientific discipline and 8+ years of experience in cGMP manufacturing operations, or an equivalent combination of education and experience.
• Experience with small-molecule synthetic chemistry and/or siRNA therapy.
• Knowledge of bulk manufacturing techniques, including chemical synthesis, downstream purification, annealing, and lyophilization.
• Basic knowledge of cGMP, FDA regulations, ICH guidelines, and EU regulations.
• Ability to lead continuous improvements, system implementations, and strategy development to reduce cycle times and improve efficiency.
• Strong interpersonal, written, and oral communication skills.

Culture & Benefits

• Inclusive workplace culture and equal employment opportunity.
• Comprehensive rewards may include bonuses or incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required by law.