Operations Manager, Cleaning & Sterilization (cGMP)

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 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.