Production Manager

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

Position Summary / Objectives

The Production Manager is responsible for leading daily manufacturing operations for collagen-based medical devices and biomaterials in a regulated GMP/ISO 13485 environment consistent with Company’s policies and objectives. This role oversees production, personnel, quality compliance, process execution, safety, scheduling, and continuous improvement activities to ensure products are manufactured safely, efficiently, and in compliance with regulatory requirements.

Position Summary / Objectives

The Production Manager is responsible for leading daily manufacturing operations for collagen-based medical devices and biomaterials in a regulated GMP/ISO 13485 environment consistent with Company’s policies and objectives. This role oversees production, personnel, quality compliance, process execution, safety, scheduling, and continuous improvement activities to ensure products are manufactured safely, efficiently, and in compliance with regulatory requirements. The Production Manager partners closely with Quality, Engineering, Supply Chain, R&D, Regulatory Affairs, and Maintenance to support production scalability, operational excellence, and customer delivery commitments.

Essential Job Functions:

• Lead all daytoday manufacturing operations across production, packaging, materials, maintenance coordination, and operational support functions.
• Develop a strong culture centered on safety, accountability, continuous improvement, and operational excellence
• Drive team performance related to safety, quality, delivery, labor efficiency, throughput, and cost control
• Manage and develop supervisors, leads, and manufacturing personnel across multiple operational areas
• Ensure manufacturing areas maintain audit readiness and compliance with FDA, GMP, and ISO requirements
• Ensure production schedules and customer delivery commitments are achieved while maintaining compliance with GMP and ISO standards.
• Investigate quality issues and prepare investigation reports deviations, CAPAs, etc.
• Initiate action to prevent the occurrence of nonconformities.
• Monitor and improve KPIs including yield, scrap, throughput, and backorders
• Drive continuous improvement initiatives focused on throughput, labor optimization, waste reduction, and process standardization
• Monitor and control production costs.
• Partner crossfunctionally with Quality, Engineering, Supply Chain, and R&D to support business objectives
• Support equipment qualification, process validation, and scaleup activities
• Participate in customer visits, audits, and operational readiness activities
• Interview and select new hires for assigned teams
• Initiate, recommend, or provide solutions through designated channels.
• Assist with various special ad hoc projects and other duties as assigned

Competencies:

• Determination
• Integrity
• Creativity
• Collaboration
• Moved by Urgency

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. The employee must occasionally lift or move office products and supplies up to 50 pounds.

Supervisory Responsibilities

This position manages employees of the department and is responsible for the performance management and hiring of the employees within that department

Education, Experience, and Certifications:

• Bachelor’s degree in engineering, manufacturing, chemistry, operations, or related field with 5+ years of leadership experience or associate’s degree in engineering or science with 10+ years’ experience in a leadership role in a regulated manufacturing.
• Experience within medical device, biotech, pharmaceutical, or biomaterials manufacturing
• Strong knowledge of GMP and ISO 13485 requirements
• Experience managing teams in a manufacturing environment
• Experience using ERP systems (SAP preferred) and Microsoft Office applications including Excel, Word, and PowerPoint for production planning, inventory management, operational reporting, data analysis, and business communication
• Strong communication, organizational, and problemsolving skills
• Ability to simultaneously track multiple projects
• Ability to manage change and grasp new concepts/ processes quickly
• Excellent communication skills (oral and written)
• Ability to identify problems and solve them.

Other Duties as Required:

Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.

Total Rewards & Benefits:

Regenity offers a comprehensive rewards package, including:

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Companypaid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range: $120-$140k

Regenity Biosciences is an Equal Opportunity Employer We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members