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.

Essential Job Functions

• 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, 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.
• Aid with various special ad hoc projects and other duties as assigned.

Competencies

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

Physical Demands

• Stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear.
• 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 or equivalent education/experience in the manufacturing, consumer goods/packaging, or food industry.
• 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 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.

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

• 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

$120,000 – $135,000

Regality 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. Regality Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.