Manufacturing Operations Leader — GMP & Scale-Up (Onsite MA)

BioSpace

Northbridge (MA)

On-site

USD 150,000 - 190,000

Full time

6 days ago
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Job summary

EyePoint is seeking an Associate Director, Manufacturing to lead day-to-day GMP manufacturing operations at the Northbridge, MA facility onsite. You will drive strategic planning, production scheduling, resource planning, and compliance with FDA requirements to deliver safe, high-quality therapies.

The role partners with Quality, Engineering, Supply Chain, Regulatory, and Product Development to ensure inspections readiness, CAPA management, and continuous improvement.

Qualifications

  • Bachelor's degree in a technical discipline required; MBA/MS preferred.
  • 8–12 years in GMP manufacturing environments.
  • 3–5 years of progressive manufacturing leadership.
  • Experience with regulatory inspections and quality system compliance preferred.

Responsibilities

  • Lead day-to-day manufacturing operations to ensure product quality, compliance, on-time delivery.
  • Develop and execute manufacturing strategies aligned with company objectives, production forecasts, and business goals.
  • Manage and develop a team of managers and manufacturing personnel across multiple shifts.
  • Establish departmental goals, staffing plans, and performance metrics.
  • Drive a culture of quality, safety, accountability, and continuous improvement.
  • Ensure manufacturing activities are conducted in accordance with cGMP requirements, approved procedures, quality systems, and regulatory expectations.

Skills

cGMP regulations
Quality systems
People management
Manufacturing planning
Cross-functional collaboration
Process validation
Budget management

Education

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations Management, or related
MBA or advanced degree preferred

Tools

Electronic quality systems

Job description

EyePoint is seeking an Associate Director, Manufacturing to lead day-to-day GMP manufacturing operations at the Northbridge, MA facility onsite. You will drive strategic planning, production scheduling, resource planning, and compliance with FDA requirements to deliver safe, high-quality therapies.

The role partners with Quality, Engineering, Supply Chain, Regulatory, and Product Development to ensure inspections readiness, CAPA management, and continuous improvement.

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