Supervisor, Operations (Cleaning & Sterilization) - 3rd shift

Axogen; Vandalia (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Axogen is seeking an Operations Supervisor to lead a shop floor team within the processing center, ensuring safe, compliant and on-time production of tissue biologics. You will oversee diverse roles, drive scheduling, and hire/retain talent while upholding quality standards across shifts.

The role requires strong leadership, GMP understanding, and the ability to adapt to changing priorities to support Axogen’s mission and patient outcomes.

Qualifications

• Available to work 3rd shift (11pm - 7:30am; Sunday night - Friday morning).
• High School Diploma required, with 3+ years of experience in a regulated manufacturing environment (FDA-regulated preferred).
• Bachelor's or Associate's Degree preferred.
• Experience leadership ability and experience coaching, leading and managing teams and individuals.
• Aptitude for understanding process technology, manufacturing equipment, and packaging equipment.
• Candidate must be flexible and respond positively to changing conditions, priorities, situations, and personnel to meet department goals and production schedule adjustments.
• Highly motivated self-starter, able to identify what needs to be done, and then reliably see this work through to successful outcomes.
• Demonstrated ability to interact effectively with all levels of the organization with strong interpersonal, teamwork, and problem-solving skills.
• Excellent oral and written communication skills.
• Understand the importance of quality management systems; GMP knowledge a plus.
• Continuous Improvement experience such as lean manufacturing, Six Sigma, DMAIC methodology.

Responsibilities

• Supervises employees and contractors engaged in production and support functions for a tissue biologic product in compliance with cGMP and regulatory requirements.
• Leads the work team, manages daily operations, ensures safety guidelines and production schedules are followed.
• Communicates new policies and procedures to shift leads and personnel promptly.
• Resolves problems at the lowest level by effective communication with all staff.
• Assesses and records training, and works with leadership to address gaps and ensure compliance.
• Assists in hiring and transferring staff to meet department goals.

Skills

Leadership ability

Coaching & mentoring

Interpersonal skills

Communication skills

Problem-solving

Flexibility

Self-motivation

Teamwork

Analytical thinking

Quality mindset

Education

High School Diploma

Bachelor's or Associate's Degree preferred

Tools

Manufacturing equipment

cGMP knowledge

Job description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Operations Supervisor

The Operations Supervisor is a shop floor leader for the growing Axogen Processing Center Operation. The scope includes a varying level of direct reports of several different job titles. Key accountabilities include day to day management of the shop floor personnel, executing the production schedule, ensuring all product is produced in a manner meeting safety and quality requirements and hiring and retaining a talented workforce. Ensures that the activities being performed in an area of responsibility is respectful of the gift of life, protects patient safety, and meets quality standards.

Requirements of the Operations Supervisor

• Available to work 3rd shift (11pm - 730am, Sunday night - Friday morning)
• High School Diploma required, with a minimum of 3+ years of experience in a regulated manufacturing environment (FDA regulated industry preferred).
• Bachelor's or Associate's Degree preferred.
• Experience leadership ability and experience coaching, leading and managing teams and individuals.
• An aptitude for understanding process technology, manufacturing equipment, and packaging equipment.
• Candidate must be flexible and respond positively to constantly changing conditions, priorities, situations, and personnel to meet varying department goals and production schedule adjustments.
• Highly motivated self-starter, able to identify what needs to be done, and then reliably see this work through to successful outcomes.
• Demonstrated ability to interact effectively with all levels of the organization with strong interpersonal, teamwork, and problem-solving skills.
• Excellent oral and written communication skills.
• Excellent leadership, documentation, and multi-tasking skills.
• Analytical and problem-solving abilities.
• Understand the importance of quality management systems.
• GMP, Tissue Processing, Cleaning and Sterilization, and/or distribution experience a plus.
• Continuous Improvement experience such as, lean manufacturing, Six Sigma, DMAIC methodology experience.

Responsibilities of the Operations Supervisor

The specific duties of the Operations Supervisor include but are not limited to:

• Supervises employees and contractors who are engaged in the production and support functions related to a tissue biologic product in compliance with current Good Manufacturing Practices (cGMP), and federal, state, and local regulations.
• Responsible for effective leadership of the work team which includes managing the daily operation ensuring that applicable safety guidelines and policies are followed; ensuring production SOP's are upheld, and production schedules are met.
• Relays all new or revised policies, procedures and processes to shift leads and personnel in a timely manner to ensure they have the most up-to-date and current information regarding operation, policy, procedural changes.
• Resolves problems, issues, and concerns at the lowest level possible by establishing an effective communication exchange between him/herself and all personnel at every tier. This should occur initially when problems arise, not in concurrence or thereafter.
• Assess and records individual and team training while working with the Senior Supervisor and/or Manager to develop a plan of action to eliminate gaps, discrepancies, and past due training to always remain in compliance.
• Assists the Senior Supervisor and Manager to hire, transfer,