Senior Manufacturing Associate - GMP & Process Leadership

BioSpace; Northbridge (MA); On-site; USD 4,968,000 - 6,480,000; Full time

Job summary

EyePoint Pharmaceuticals is seeking a Senior Manufacturing Associate to lead and execute complex manufacturing, assembly, packaging, labeling, and inspection for combination products in a GMP environment. You will serve as SME, train staff, and drive process improvements while ensuring compliance and product quality.

This role requires 5+ years in regulated manufacturing and a strong background in device/biopharma production, with a focus on documentation, problem-solving, and cross-functional

Qualifications

• 5+ years in regulated manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing.
• Experience supporting investigations, process improvements, equipment troubleshooting, and training.
• Prior experience as lead operator, trainer, or SME preferred.

Responsibilities

• Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
• Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
• Set up, operate, troubleshoot, and perform advanced process adjustments on manufacturing equipment.
• Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
• Identify, investigate, and resolve manufacturing issues while ensuring compliance with procedures and quality requirements.
• Lead or support deviation investigations, nonconformance investigations, root cause analyses, CAPAs, and other quality activities.
• Support process validation, equipment qualification, engineering studies, and technology transfer.
• Develop, revise, and improve manufacturing procedures, work instructions, forms, and training materials.
• Train, mentor, and qualify manufacturing personnel while supporting onboarding and development programs.
• Partner with Quality, Engineering, Supply Chain, and Regulatory teams to support objectives and compliance initiatives.
• Drive continuous improvement initiatives focused on productivity, quality, cost reduction, safety, and efficiency.
• Monitor manufacturing metrics and recommend process improvements based on data analysis.
• Assist leadership in capacity planning, production readiness, and scheduling support.
• Maintain production areas in a state of inspection readiness.
• Promote a culture of safety, quality, accountability, and continuous improvement.

Skills

cGMP knowledge

GDP basics

Quality systems

Manufacturing expertise

Root cause analysis

Training & mentoring

Equipment troubleshooting

Documentation practices

Education

High School Diploma or GED

Associate's or Bachelor's degree in Engineering/Life Sciences/Manufacturing

Tools

Electronic Quality Management System

Job description

EyePoint Pharmaceuticals is seeking a Senior Manufacturing Associate to lead and execute complex manufacturing, assembly, packaging, labeling, and inspection for combination products in a GMP environment. You will serve as SME, train staff, and drive process improvements while ensuring compliance and product quality.

This role requires 5+ years in regulated manufacturing and a strong background in device/biopharma production, with a focus on documentation, problem-solving, and cross-functional