A

Axogen

Specializes in peripheral nerve repair devices

Operations Supervisor - Operations, Cleaning & Sterilization

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeVandalia, OH, USAIn-person

About the Job

Requirements

  • A high school diploma is required, along with at least 3 years of experience in a regulated manufacturing environment; experience in an FDA-regulated industry is preferred.
  • Leadership ability and experience coaching, leading, and managing teams and individuals are required.
  • An aptitude for understanding process technology, manufacturing equipment, and packaging equipment is required.
  • The candidate must be flexible and respond positively to changing conditions, priorities, situations, and personnel to meet department goals and production schedule adjustments.
  • The candidate must be able to identify work that needs to be done and reliably see it through to successful outcomes.
  • The candidate must be able to interact effectively with all organizational levels and demonstrate interpersonal, teamwork, and problem-solving skills.
  • Strong oral and written communication, leadership, documentation, and multitasking skills are required.
  • Analytical and problem-solving abilities are required.
  • The candidate must understand the importance of quality management systems.
  • The candidate must be available to work the third shift, 11 p.m. to 7:30 a.m., Sunday night through Friday morning.
  • The candidate must be able to cover the assigned on-call schedule, including holidays.

Responsibilities

  • Supervise employees and contractors engaged in production and support functions for a tissue biologic product in compliance with current Good Manufacturing Practices and federal, state, and local regulations.
  • Lead the work team and manage daily operations, ensuring safety guidelines and policies are followed, production standard operating procedures are upheld, and production schedules are met.
  • Communicate new or revised policies, procedures, and processes to shift leads and personnel promptly so they have current operational information.
  • Resolve problems, issues, and concerns at the lowest appropriate level by establishing effective communication with personnel at every tier when issues arise.
  • Assess and record individual and team training, and work with the Senior Supervisor and/or Manager to develop action plans that address training gaps, discrepancies, and overdue training.
  • Assist the Senior Supervisor and Manager, with Human Resources, in hiring, transferring, promoting, discharging, disciplining, and assigning work to employees.
  • Identify effective and ineffective practices, recommend corrective or sustaining actions to the Senior Supervisor, and help resolve issues.
  • Hold one-on-one meetings with direct reports to counsel them, support their development, and provide corrective action when necessary.
  • Promote team-member engagement and ownership, ensuring colleagues feel their contributions are valued and meaningful to the success of the processing center and company.
  • Perform other duties as assigned.

Desired Qualifications

  • A Bachelor’s or Associate’s degree is preferred.
  • Good Manufacturing Practices, tissue processing, cleaning and sterilization, and/or distribution experience is a plus.
  • Experience with continuous improvement methods such as lean manufacturing, Six Sigma, or DMAIC is desirable.

About the Company

Axogen

Specializes in peripheral nerve repair devices

AxoGen develops and sells surgical solutions for peripheral nerve repair. Its core products include Avance Nerve Graft, a processed human nerve allograft that bridges nerve gaps without a second surgical site, and Axoguard devices for nerve coaptation, protection, and neuroma reduction. The products are distributed directly to hospitals and surgical centers, targeting plastic, hand, and oral/maxillofacial surgeons. The goal is to improve nerve repair outcomes and grow a sustainable business in the U.S. nerve repair market by offering clinically proven, FDA-cleared tissue grafts and devices.

Company size
501-1,000
Company stage
IPO
Headquarters
Alachua, FL
Founded
2002

Recently Posted Jobs

Explore more opportunities at Axogen

See more jobs