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.

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.

• Lead all day-to-day 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 of 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 scale-up 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 in a regulated manufacturing.
• Experience with in 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 problem‑solving 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.

Applicants must be authorized to work in the United States on a full‑time basis. This position does not offer visa sponsorship or transfer of sponsorship at this time.