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

About the role

Axogen’s new Manager, Operations will oversee assigned departments within the APC facility—Cleaning & Sterilization, Materials & Warehousing, or Tissue Processing & Debridement—while demonstrating the ability to understand and manage all operational activities. The role requires applying operational, quality, safety, and regulatory skill sets to oversee assigned operations and personnel, implement cost control measures, and lead productivity projects to improve overall company performance.

Responsibilities

• Oversee employee recruiting, selection, orientation, and training through supervisors and lead technicians.
• Manage all levels of employees, set annual goals/objectives, and evaluate performance.
• Ensure a safe, secure, and legally compliant work environment.
• Develop personal growth opportunities and coach, counsel, and discipline employees.
• Mentor, train, and develop Operations Supervisors on procedures, processes, and career development; foster teamwork and open communication.
• Develop, coordinate, and enforce systems, policies, procedures, and productivity standards.
• Define objectives, evaluate trends, choose courses of action, and assess outcomes.
• Maintain quality service by enforcing standards, resolving quality and processing problems, and recommending improvements.
• Establish and maintain cooperative cross-functional relationships with peers in Quality, Operations, R&D, and other departments.
• Oversee employees and contractors engaged in production and support functions related to tissue biologic products in compliance with cGMP and federal, state, and local regulations.
• Develop and align operational metrics for safety, quality, delivery, productivity (cost), and people (morale); lead the team to meet these goals.
• Assist R&D and Process Development in in-house manufacturing product launches, including hiring, training, process development input, and production planning.
• Partner with HR and senior leadership on hiring, transfers, promotions, discipline, and compensation changes.
• Conduct strategic planning and quarterly forecasting to support finance and supply chain with accurate financial forecasts and budgeting.
• Proactively identify gaps in strategy and resources and develop mitigation plans.
• Support all regulatory inspections including FDA, BSI (ISO), and AATB.

Requirements

• 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.
• cGMP, Cleaning and Sterilization, tissue, biologics or pharma, medical device, and distribution experience a plus.
• Knowledge of FDA/cGMP requirements or other regulated operational knowledge/experience.
• Ability to lead and manage change management initiatives.
• Analytical and problem-solving abilities; ability to lead and develop teams to build problem-solving skills.
• Understand the importance of quality management systems and establish them within the team.
• Experience with continuous improvement methodologies such as lean manufacturing, Six Sigma, or DMAIC.
• Ability to travel at least 10% required.

Benefits

• Health, Dental, Vision insurance
• Matching 401(k)
• Paid Time Off and 9 Paid Holidays + 3 Floating Holidays
• Dependent Care and Medical Flexible Spending Accounts
• Tuition Reimbursement
• Paid Parental Leave and Paid Caregiver Leave
• Basic and Supplemental Life Insurance
• Employee Stock Purchase Plan
• Disability Insurance

Pay

Salary Range: $92,293—$115,367 USD

Schedule

Location: 913 Industrial Drive, Vandalia, OH 45377