Production Manager

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 cross functionally 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

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

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.

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

• 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…