Director, Orthobiologics Manufacturing.
This position is a key member of the Aziyo Biologics team, responsible for achieving the Company’s goals in orthobiologics manufacturing excellence.
This leader is responsible for all aspects of the tissue manufacturing operations that must be conducted in accordance with local, state, and federal statutes and regulations. The leader will manage an experienced team of professional, technical and logistic experts responsible for various phases of operations and continue to build the team through talent identification and training. The individual will ensure that manufacturing plans, capacity requirements, and customer standards are met while seeking continuous improvement and greater efficiencies.
Position reports to the Vice President of Global Operations.
Essential Duties & Responsibilities
- Provides leadership for all aspects of tissue processing, packaging, logistics and procedures, staff development, in accordance with FDA Good Tissue Practices (cGTP) and other applicable requirements.
- Analyzes and reports data on tissue processing efficiency and related outcomes to improve processes and compliance.
- Leads development, tech transfer and implementation of new procedures.
- Identifies and implements manufacturing improvements.
- Manages staff including performance appraisals, training and safety programs.
- Ensures all quality control and quality assurance guidelines for tissue processing are in place and met.
- Oversees internal audits of processes according to standard operating procedures (SOP).
- Works closely with supply chain personnel to ensure adequate availability of donors, materials and equipment.
- Ensure facility activities and processes incorporate Universal Precautions in the presence of potential bloodborne pathogens (BBP).
- Safely handle dry ice and materials stored at – 80°C.
- Performs other related duties as needed in response to company goals and direction.
Bachelor’s or Master’s degree in operations management, life sciences or engineering field.
Experience and Skills
Work Experience Required:
5-10 years of increasing responsibility in operations and manufacturing in a FDA regulated environment.
Specialized Skills, Knowledge:
- Demonstrated leadership of diverse, interdisciplinary teams.
- Demonstrated experience in managing complex supply chains and procurement.
- Experience in audits by US and international authorities and customers.
- Thorough knowledge of MRP/ERP systems.
- Experience in complex inventory planning and control systems.
- Highly skilled in complex problem solving and troubleshooting of technical issues.
- Excellent verbal and written communication skills.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.
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