Manager, CMC Operations Program Management (Cell and Gene Therapy)

Location: Waltham, Massachusetts, United States; hybrid with 2–3 days onsite per week

Salary: $125,000–$165,000 per year

Company

hirify.global is a technology-driven biotechnology company developing advanced therapies through integrated technologies, end-to-end services, and manufacturing expertise.

What you will do

• Lead cross-functional CMC activities across process development, analytical development, facilities and engineering, MSAT, manufacturing, supply chain, quality, regulatory, and commercial teams.
• Build and maintain detailed CMC project plans covering milestones, deliverables, budgets, and resources.
• Coordinate internal and partner meetings to improve communication, decision-making, and program execution.
• Identify risks, gaps, and resource bottlenecks, then develop and implement mitigation plans.
• Create dashboards, maintain risk registers, decision logs, and change requests, and prepare content for Joint Leadership Meetings.
• Support process standardization, KPI management, partner milestone reviews, and invoicing coordination with finance and department leads.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• At least 3 years of relevant experience in a CMC environment; cell and gene therapy experience is preferred.
• Required experience in cGMP program management and leading product or process programs in a GMP setting.
• Program management experience with budgets, milestones, metrics, reporting, and related planning tools.
• Strong verbal and written communication, interpersonal, technical, troubleshooting, planning, organization, and multitasking skills.
• Knowledge of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred.

Culture & Benefits

• Regular employment based at the hirify.global BaseCamp site.
• Hybrid work arrangement with 2–3 onsite days each week.
• Work across internal portfolios and external partner programs.
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.