Production Lead - Medical Devices (GMP/ISO)

Regenity Biosciences; Allendale (NJ); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Company performance bonus eligibility

401(k) plan with company contribution

Paid time off and paid holidays

Medical, prescription, dental, and vis

Company-paid life and AD&D insurance

Wellness Program and EAP

Tuition Reimbursement

Job summary

Regenity Biosciences in Allendale, NJ is seeking a Production Manager to lead daily manufacturing operations for collagen-based devices in a GMP/ISO 13485 environment. You will oversee production, quality, safety, scheduling, and continuous improvement while partnering with Quality, Engineering, Supply Chain, and R&D to support scaling and on-time delivery.

The role requires 5+ years of leadership in regulated manufacturing, strong GMP/ISO knowledge, and experience with ERP systems (SAP) and

Qualifications

• Bachelor’s degree in engineering or related field required with leadership experience.
• Experience in regulated manufacturing, preferably medical devices or biotech.
• GMP and ISO 13485 knowledge and hands-on ERP usage in production planning.
• Strong communication, organization, and problem-solving skills.

Responsibilities

• Lead daily manufacturing operations across production, packaging, materials, and maintenance.
• Develop safety culture and drive accountability, continuous improvement, and efficiency.
• Manage supervisors and manufacturing personnel across multiple areas.
• Ensure audit readiness and compliance with FDA, GMP, ISO13485.
• Coordinate production schedules with customer delivery commitments.
• Investigate quality issues and drive CAPAs and deviations.
• Monitor KPIs: yield, throughput, cost control, and on-time delivery.
• Support qualification, validation, and scale-up activities.
• Participate in staffing and hiring for the department.

Skills

Leadership

Operations

GMP/ISO

Data analysis

Communication

Education

Bachelor’s degree in engineering or related field

Tools

SAP

Microsoft Excel

PowerPoint

Job description

Regenity Biosciences in Allendale, NJ is seeking a Production Manager to lead daily manufacturing operations for collagen-based devices in a GMP/ISO 13485 environment. You will oversee production, quality, safety, scheduling, and continuous improvement while partnering with Quality, Engineering, Supply Chain, and R&D to support scaling and on-time delivery.

The role requires 5+ years of leadership in regulated manufacturing, strong GMP/ISO knowledge, and experience with ERP systems (SAP) and