Production Manager

Production Manager Regenity Oakland, NJ Job Details Full-time $120,000 - $135,000 a year 21 hours ago Benefits Wellness program AD&D insurance Paid holidays Health insurance Dental insurance 401(k) Tuition reimbursement Paid time off Employee assistance program Vision insurance 401(k) matching Qualifications Staff supervision Microsoft Excel Production data analysis Team leadership ISO standards Data reporting GMP Inventory management software Manufacturing facility Production management software Regulatory/legal compliance standards in production Quality standards in production Biomedical regulatory compliance Managing manufacturing teams Productivity software Data analysis software Full 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. 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. 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. 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:

$120,000 - $135,000 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. About Regenity Collagen Matrix is now Regenity Biosciences. Regenity Biosciences advances new frontiers in regenerative science, turning bioabsorbable materials into life-changing solutions. Sought after for our novel resorbable technologies and distinct approach to contract manufacturing and contract development, our team brings the urgency and vision to deliver breakthrough medtech solutions for medical technology and medical device manufacturers of all sizes. For more than 25 years, Regenity Biosciences has been transforming bioabsorbable materials into regenerative solutions to repair and regenerate tissue and bone we have since introduced numerous bioresorbable technologies with more than 71 product lines commercially available worldwide. Most recently, Regenity expanded its product portfolio to include versatile bioresorbable polymer technologies via the acquisition of Polyganics, which was the impetus behind the new name and brand direction.