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

Axogen•Vandalia, OH

2d•$92,293 - $115,367•Onsite

About The Position

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. The Cleaning & Sanitation department is BRAND NEW!

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 required.
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

Nice To Haves

cGMP, Cleaning and Sterilization, tissue, biologics or pharma, medical device and distribution experience a plus.

Responsibilities

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.