Associate Director, Manufacturing Operations (Biopharmaceutical Manufacturing)

Location: Onsite at the Northbridge, Massachusetts facility

Salary: $150,000–$190,207 USD annually

Company

hirify.global is a specialty biopharmaceutical company developing and commercializing ophthalmic products for serious eye disorders.

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, budgets, and capacity plans.
• Manage and develop manufacturing managers, senior associates, and production personnel across multiple shifts.
• Partner with Quality, Engineering, Supply Chain, Regulatory, and Product Development to maintain operational excellence and inspection readiness.
• Lead manufacturing investigations, deviations, nonconformances, CAPA activities, audits, and regulatory inspection support.
• Drive new product introductions, process transfers, scale-up, commercialization, validation, equipment qualification, and automation improvements.

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.
• At least 3–5 years of progressive manufacturing leadership experience.
• Experience with combination products, medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Advanced knowledge of cGMP regulations, FDA requirements, quality systems, lean manufacturing, CAPA, validation, and technology transfer.
• Demonstrated experience leading teams through commercial production, scale-up, inspections, and operational improvements.

Nice to have

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

Culture & Benefits

• Work focused on developing therapies intended to prevent blindness and improve outcomes for patients with serious retinal diseases.
• Culture centered on transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Commitment to fair and equitable compensation practices.
• Equal opportunity employment and an inclusive candidate selection process.