Associate Director, Manufacturing Operations (Biotech)

Location: Onsite at the Northbridge, Massachusetts facility, United States

Salary: $150,000–$190,207 USD per year

Company

hirify.global is an ophthalmology company developing and commercializing innovative therapeutics aimed at preventing blindness and treating serious retinal diseases.

What you will do

• Lead day-to-day manufacturing operations for commercial and clinical GMP-regulated combination products.
• Develop manufacturing strategies, production schedules, staffing plans, performance metrics, and capacity plans.
• Manage and develop manufacturing managers, senior associates, and personnel across multiple shifts.
• Partner with Quality, Engineering, Supply Chain, Regulatory, and Product Development to maintain compliance and operational excellence.
• Lead manufacturing readiness for product introductions, process transfers, scale-up, commercialization, validation, and equipment qualification.
• Manage investigations, deviations, nonconformances, CAPA activities, audits, budgets, capital expenditures, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations Management, or a related technical discipline.
• 8–12 years of experience in GMP-regulated manufacturing environments and 3–5 years of progressive manufacturing leadership experience.
• Experience with combination products, medical devices, pharmaceuticals, biotechnology, or another regulated industry.
• Advanced knowledge of cGMP regulations, FDA requirements, quality systems, lean manufacturing, validation, equipment qualification, and technology transfer.
• Experience leading teams through commercial production, scale-up, inspections, investigations, CAPA activities, and operational improvements.
• Strong analytical, organizational, decision-making, communication, budget management, and cross-functional collaboration skills.

Nice to have

• Advanced degree such as an MBA, MS, or similar.
• Experience supporting regulatory inspections and quality system compliance activities.

Culture & Benefits

• Focus on patient safety, product integrity, regulatory compliance, and continuous improvement.
• Values include transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Commitment to a diverse, equitable, and inclusive workplace.