We are GROWING! Manager, Operations (Cleaning & Sterilization)

axogen; Vandalia (OH); On-site; USD 92,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Health, dental, vision

Matching 401K

Paid time off

Floating holidays

Employee Stock Purchase Plan

Educational assistance

Referral incentive program

Tuition reimbursement

Job summary

Axogen is seeking a Manager, Operations in Vandalia, OH to lead Cleaning & Sterilization, Materials & Warehousing, or Tissue Processing operations. You will guide safety, quality, and productivity efforts while managing a team and ensuring regulatory compliance.

The role emphasizes cross‑functional collaboration, performance management, and continuous improvement; a bachelor’s degree and 5+ years in operations or QA within medical devices or biotech are required.

Qualifications

• Minimum 5 years of experience in Operations or Quality Assurance in medical device, pharmaceutical, or biotech manufacturing.
• Minimum 3 years of leading others or project management experience.
• Bachelor’s Degree in Life Science or Engineering discipline and/or a related field.
• Demonstrated leadership, communication, time management and cGMP documentation skills.
• cGMP, Cleaning and Sterilization, tissue, biologics or pharma, medical device and distribution experience a plus.
• Knowledge of FDA/cGMP requirements or other regulated operations experience.
• Ability to lead change management with workforce.
• Analytical and problem‑solving abilities; develop team problem solving skills.
• Understand quality management systems and implement them within teams.
• Continuous Improvement: lean manufacturing, Six Sigma, DMAIC.

Responsibilities

• Oversee assigned operations and personnel within APC facility.
• Ensure safe, compliant operations adhering to cGMP and FDA regulations.
• Develop staff growth opportunities and manage performance.
• Mentor Supervisors and develop procedures for safe and efficient work.
• Define objectives, evaluate trends, and choose courses of action.
• Maintain quality service and resolve processing problems.
• Foster cross‑functional collaboration with Quality, R&D and other departments.
• Oversee production support for tissue biologic products following regulatory standards.

Skills

Operations management

Leadership

Project management

cGMP knowledge

FDA regulations

Quality management systems

Lean Six Sigma

Problem solving

Communication

Analytical skills

Education

Bachelor’s degree in Life Science or Engineering

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!

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.

The Cleaning & Sanitation department is BRAND NEW!

Job Summary Of The Manager, Operations

The Manager, Operations will have assigned departments within the APC facility of either Cleaning & Sterilization, Materials & Warehousing, or Tissue Processing & Debridement, but will demonstrate the ability to understand and manage all operational activities within the facility while adhering to all safety, cGMP and FDA regulations in the facility. The primary responsibility is to oversee assigned operations and personnel within the APC facility where multiple requirements and challenges will exist requiring the ability to apply good working knowledge of operational, quality, safety, and regulatory skill sets. The Manager, Operations will also be responsible for cost control measures and productivity projects to improve overall company performance for assigned areas.

Requirements Of The Manager, Operations

• Minimum 5 years of experience in Operations or Quality Assurance in medical device, pharmaceutical, or biotech manufacturing.
• Minimum 3 years of leading others or project management, direct people management preferred.
• Bachelor’s Degree in Life Science or Engineering discipline and/or a related field.
• Demonstrated leadership, communication, time management/organizational and cGMP documentation skills required.
• cGMP, Cleaning and Sterilization, tissue, biologics or pharma, medical device and distribution experience a plus.
• Must have knowledge of FDA/cGMP requirements or other regulated operational knowledge/experience.
• Ability to lead and manage change management with workforce.
• Analytical and problem‑solving abilities. Also should possess ability to lead and develop team to build out problem solving skills within their operation.
• Understand the importance of quality management systems and establish this within their team.
• Continuous Improvement such as, lean manufacturing, Six Sigma, DMAIC methodology experience.
• Ability to travel at least 10% required

Responsibilities Of The Manager, Operations

• Oversees employee recruiting, selecting, orienting, and training employees through supervisors and lead technicians. Accomplishes department objectives by managing all levels of employees, including planning and evaluating department activities such as setting annual goals, objectives, and annual performance activities.
• Ensures a safe, secure, and legal work environment.
• Develops personal growth opportunities. Accomplishes staff results by communicating job expectations, planning, monitoring, and appraising job results. Coaches, counsels, and disciplines employees.
• Mentors, trains, and develops Operation Supervisors on procedures and processes for safe and efficient performance and assists in their career development; creates an atmosphere of team effort & open communication.
• Develops, coordinates, and enforces systems, policies, procedures, and productivity standards.
• Defines objectives, identifies, and evaluates trends and options, chooses a course of action, and evaluates outcomes.
• Maintains quality service by enforcing quality and organizational standards, analyzing and resolving quality and processing problems, and recommending improvements.
• Establishes and maintains cooperative cross‑functional relationships with peers in Quality, Operations, R&D, and other Axogen departments to meet planned objectives.
• Oversees 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 and consults with assistance from Operation Supervisors.
• Responsible for developing and aligning operational metrics related to safety, quality, delivery, productivity (cost) and people (morale) and leading team to meet these goals and objectives.
• Assists R&D and Process Development in creating in‑house manufacturing product launches, which may include hiring, training, process development input and recommendations and production planning to meet timelines.
• Executes actions while partnering with HR and senior leadership such as hiring, transfers, promotions, discharges, assignments, discipline, and compensation changes for assigned employees with the assistance of Human Resources.
• Strategic planning and forecasting of production broken out by quarter for the entire planned year to assist finance and supply chain on accurate financial forecasts and budgeting.
• Proactively identifies any gaps in strategy and resources and develops and communicates plan to mitigate.
• Supports all regulatory inspections including FDA, BSI (ISO) and AATB.
• All other duties as assigned.

Location

913 Industrial Drive Place, Vandalia, OH 45377

Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$92,293—$115,367 USD

Company Statements

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.