Senior Manufacturing Operations Leader, GMP & Scale-Up

BioSpace; Northbridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

EyePoint seeks an Associate Director of Manufacturing to lead end-to-end GMP-regulated production for combination products at the Northbridge, MA site. You will partner with Quality, Engineering, Supply Chain, Regulatory and Product Development to drive operational excellence and inspection readiness.

The role reports to Sr. Director, Manufacturing & Technical Operations and oversees multi-shift teams, while aligning manufacturing strategies with forecasts and budget objectives.

Qualifications

• Bachelor's degree in a technical field is required; advanced degree preferred.
• 8–12 years GMP manufacturing experience with 3–5 years in leadership.
• Experience with combination products, medical devices, or biotech regulatory environments.

Responsibilities

• Lead day-to-day manufacturing operations ensuring quality and on-time delivery.
• Develop strategies aligned with production forecasts and business goals.
• Manage and develop a multi-shift manufacturing team.
• Ensure compliance with cGMP, quality systems, and regulatory expectations.
• Support regulatory inspections, audits, and CAPA activities.
• Collaborate with Quality, Engineering, Supply Chain and Product Development.

Skills

cGMP compliance

Regulatory readiness

Manufacturing leadership

Lean manufacturing

CAPA & investigations

Budget management

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Engineering/Life Sciences/related

MBA/MS preferred

Tools

Electronic Quality Systems

Manufacturing reporting tools

Job description

EyePoint seeks an Associate Director of Manufacturing to lead end-to-end GMP-regulated production for combination products at the Northbridge, MA site. You will partner with Quality, Engineering, Supply Chain, Regulatory and Product Development to drive operational excellence and inspection readiness.

The role reports to Sr. Director, Manufacturing & Technical Operations and oversees multi-shift teams, while aligning manufacturing strategies with forecasts and budget objectives.