Associate Director, Manufacturing Operations
EyePoint
August 13, 2026
On-site
Northbridge, MA
Operations
Associate Director, Manufacturing (onsite, Northbridge, MA)
Responsibilities:
- Lead day-to-day GMP manufacturing to ensure quality, compliance, on-time delivery, and efficiency.
- Develop and execute manufacturing strategies; manage and develop multi-shift manufacturing teams.
- Set goals, staffing plans, and performance metrics; drive quality, safety, accountability, and continuous improvement.
- Ensure cGMP compliance with procedures, quality systems, and regulatory expectations.
- Partner with Supply Chain/Planning to meet schedules, materials availability, and capacity needs.
- Monitor performance metrics; drive improvements in throughput, efficiency, quality, and cost.
- Oversee investigations, deviations, nonconformances, and CAPA resolution.
- Support inspections/audits (regulatory, customer, internal) and maintain inspection readiness.
- Lead manufacturing readiness for new products/process transfers/scale-ups/commercialization.
- Support process validation, equipment qualification, facility expansion, and technology transfer.
- Manage departmental budgets/capex/OPEX; partner with Engineering on equipment/automation/process improvements.
- Assess capacity and build workforce/infrastructure plans; review/approve procedures, training, and production documentation.
- Establish succession planning and lead cross-functional operational excellence initiatives; ensure safety/environmental/workplace health compliance.
Qualifications & Skills (Required unless noted):
- Advanced cGMP, FDA, and quality system knowledge; combination product manufacturing knowledge.
- Manufacturing planning/scheduling/capacity management expertise; proven leadership/people management.
- Lean/continuous improvement/operational excellence; experience with investigations/CAPAs.
- Knowledge of manufacturing validation, equipment qualification, technology transfer; budget management.
- Strong organization/analytics/decision-making; influence cross-functional teams.
- Excellent written/verbal communication; proficiency with electronic quality systems/reporting tools.
- Bachelor’s degree in Engineering/Life Sciences/Pharma Sciences/Operations Management or related field.
- 8–12 years in GMP-regulated manufacturing; 3–5 years progressive manufacturing leadership; experience in combination products/medical devices/pharma/biotech or other regulated industries.
Preferred: MBA/MS.
Salary Range: $150,000–$190,207 USD.
Responsibilities:
- Lead day-to-day GMP manufacturing to ensure quality, compliance, on-time delivery, and efficiency.
- Develop and execute manufacturing strategies; manage and develop multi-shift manufacturing teams.
- Set goals, staffing plans, and performance metrics; drive quality, safety, accountability, and continuous improvement.
- Ensure cGMP compliance with procedures, quality systems, and regulatory expectations.
- Partner with Supply Chain/Planning to meet schedules, materials availability, and capacity needs.
- Monitor performance metrics; drive improvements in throughput, efficiency, quality, and cost.
- Oversee investigations, deviations, nonconformances, and CAPA resolution.
- Support inspections/audits (regulatory, customer, internal) and maintain inspection readiness.
- Lead manufacturing readiness for new products/process transfers/scale-ups/commercialization.
- Support process validation, equipment qualification, facility expansion, and technology transfer.
- Manage departmental budgets/capex/OPEX; partner with Engineering on equipment/automation/process improvements.
- Assess capacity and build workforce/infrastructure plans; review/approve procedures, training, and production documentation.
- Establish succession planning and lead cross-functional operational excellence initiatives; ensure safety/environmental/workplace health compliance.
Qualifications & Skills (Required unless noted):
- Advanced cGMP, FDA, and quality system knowledge; combination product manufacturing knowledge.
- Manufacturing planning/scheduling/capacity management expertise; proven leadership/people management.
- Lean/continuous improvement/operational excellence; experience with investigations/CAPAs.
- Knowledge of manufacturing validation, equipment qualification, technology transfer; budget management.
- Strong organization/analytics/decision-making; influence cross-functional teams.
- Excellent written/verbal communication; proficiency with electronic quality systems/reporting tools.
- Bachelor’s degree in Engineering/Life Sciences/Pharma Sciences/Operations Management or related field.
- 8–12 years in GMP-regulated manufacturing; 3–5 years progressive manufacturing leadership; experience in combination products/medical devices/pharma/biotech or other regulated industries.
Preferred: MBA/MS.
Salary Range: $150,000–$190,207 USD.