The Tissue Bank Manager/Production Manager is responsible for planning, directing, and controlling tissue processing operations within a regulated tissue bank environment. This role ensures that human tissue products are processed, handled, and packaged in accordance with applicable standards, regulations, and internal quality control procedures.

The Tissue Bank Manager/Production Manager oversees daily cleanroom operations, staff supervision, workflow scheduling, and equipment utilization to ensure timely and compliant production. They collaborate closely with Quality Assurance, Regulatory Affairs, and Operations to maintain traceability, documentation accuracy, and adherence to good tissue practices.

This role is also responsible for continuous process improvement, training and competency of processing technicians, investigation of deviations, and implementation of corrective and preventive actions (CAPA). The Production Manager ensures optimal throughput while maintaining strict sterility, environmental controls, and donor-to-recipient traceability.

Duties and Responsibilities

• Receipt, Inspection & Storage of Incoming Tissue Donors
• Preparation of Tissue Donors and Clean Room(s) for Processing Including:
  • Inspection & Aseptic Preparation of Supplies
  • Transportation of Tissue Donor to Clean Room
  • Preparation of Clean Room(s) & Related Equipment for Processing
  • Documentation of Process & Related Environmental Requirements
• Performing, Instructing & Managing the Manufacturing of Tissue Donors Including:
  • Debriding
  • Cutting
  • Rinsing
  • Lyophilization
  • Grinding
  • Decalcification
  • Packaging
  • Shipping
• Routine Cleaning Requirements of Clean Room(s)
• Disposal of Biohazardous Waste
• Data Entry of Manufacturing Process (ERP Data Entry, Batch Record(s), Paperwork, Etc.) 
• Direct Knowledge of Working Equipment
• Direct Knowledge and Strong Familiarity with Tissue Innovations Standard Operating Procedures
• Competence in Tissue Banking and/or Sterile Manufacturing Environments
• Proficient in Preceptor Training of Subordinates
• Management & Performance of Other Tasks & Functions as Needed by Management

Working Conditions

• Although rare, there may be some on-call and weekends required in this role.
• Warehouse, Cleanroom & Aseptic Environment with Cool Temperatures
• The use of heavy machinery is in an enclosed area that may lead to a loud working environment.

Physical Requirements

• Extensive Periods of Standing
• Ability to Lift, Push, and Pull 50lbs. Unassisted

About Tissue Innovations, LLC

Tissue Innovations is an emerging research and manufacturing company specializing in human cellular and tissue-based products. With a leadership team boasting decades of experience in the industry, we are dedicated to honoring the gift of donation and enhancing a patient's quality of life through positive outcomes.

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