External Manufacturing Specialist (Advanced Therapies)

Location: East Greenbush, New York, United States; onsite role, Monday–Friday, 8:00am–4:30pm; travel up to 25%

Salary: $62,355–$110,000 annually

Company

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

What you will do

• Act as the operational contact for contract manufacturing organizations and partner sites.
• Coordinate batch scheduling, material supply, shipments, cycle-time tracking, documentation, and associated technical support.
• Collaborate with Quality Control, Quality Assurance, Supply Chain, Operations, Logistics, and external manufacturing partners.
• Support investigations, critical initiatives, long-term contracts, and relationship stability with manufacturing partners.
• Monitor cGMP compliance and product integrity at contract manufacturers and business partners.
• Support technology transfer and development work, and review pre-production and executed master batch records.

Requirements

• BS/BA in a scientific field or an equivalent combination of education and experience.
• Relevant cGMP manufacturing operations experience: 0–2 years for Associate Specialist or 2+ years for Specialist; level depends on experience.
• Experience with synthetic processes, small-molecule synthesis, antibody-drug conjugates, or fermentation.
• Knowledge of bulk manufacturing techniques, including fermentation, chemical synthesis, downstream purification, conjugation, or formulation.
• Basic knowledge of cGMP, FDA regulations, ICH guidelines, and EU regulations.
• Strong interpersonal, written, and oral communication skills, with the ability to work toward goals with minimal supervision in a dynamic environment.

Culture & Benefits

• Inclusive workplace and equal-opportunity employment environment.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during recruitment where required.
• Background checks may verify identity, right to work, and educational qualifications.