Staff Process Specialist, Fill Finish Manufacturing

Location: East Greenbush, New York, United States. Onsite work, Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $92,200–$206,100 annually.

Company

hirify.global develops science-driven medicines for people with serious diseases.

What you will do

• Provide on-the-floor technical direction, resolve process problems, and coach manufacturing personnel on critical process steps.
• Lead investigations into process variances, implement CAPAs, and guide equipment and process validation activities.
• Support technology transfer, manufacturing startup, and collaboration with Process Science and technology transfer teams.
• Track, analyze, and present technical and business process metrics and prepare reports for the Process Science Group.
• Write, review, and approve SOPs, specifications, regulatory filings, and other controlled documents; support cGMP and regulatory audits.
• Own defined manufacturing equipment and lead continuous improvement and safety initiatives in collaboration with technical and engineering teams.

Requirements

• BS in Life Sciences or a related field; an equivalent combination of education and experience may be considered.
• 10+ years of relevant cGMP manufacturing, engineering, or scientific experience for the Staff level.
• Knowledge of cGMP manufacturing and formulation, aseptic filling, visual inspection, assembly, labeling, or packaging of liquid and lyophilized injectable products.
• Experience with technology transfer and equipment or process validation in aseptic parenteral fill-finish operations is preferred.
• Ability to wear full cleanroom attire, remove jewelry and personal adornments, and perform physical requirements for shifts of up to 10 hours in a cleanroom environment.

Nice to have

• Experience with lyophilization.
• Experience operating and qualifying highly automated equipment.

Culture & Benefits

• Science-driven work focused on developing life-changing medicines.
• Inclusive workplace with reasonable accommodations available where required.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.