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DIRECTOR OF MANUFACTURING
Make a direct impact on the life of another by being a member of a very unique team of individuals. Community Tissue Services (CTS) is a not-for-profit tissue bank founded and headquartered in Dayton OH. CTS proudly serves the public through recovery, processing and distribution of human tissue grafts used for transplantation in life-saving and life-enhancing procedures. CTS is currently one of the largest US tissue banks, distributing nearly 10% of the tissue grafts in the United States. We are the largest nonprofit provider of skin grafts to surgeons for severe burn patients. CTS is accredited by the American Association of Tissue Banks (AATB), and strives to be on the forefront of new graft development and biotechnology to better serve recipients and medical professionals.
The Director of Manufacturing, working with the Executive Director of Manufacturing, is responsible for developing, directing and implementing the activities of the Manufacturing Department to ensure that manufacturing processes are predictable, cost effective and reliable. Consistently demonstrates integration of CBC/CTS quality policy and guiding principles by modeling behavior that supports achieving our mission and vision. Supports and incorporates CBC/CTS business needs, goals, and performance indicators into all business decisions and actions. Exhibits support of our values, quality objectives, ethics, customer service, and confidentiality standards at all times.
Routinely performs duties in compliance with all applicable regulatory and accrediting agencies, including but not limited to Occupational Safety and Health Administration (OSHA) regulations, the current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), American Association of Tissue Banks (AATB), and the Food and Drug Administration (FDA).
CORE JOB FUNCTIONS
Select, train, orient, supervise, evaluate, develop and counsel employees.
Provide coaching to staff to ensure effective conduct of manufacturing operations. Motivate and direct team, set goals, objectives and priorities, assign and review work of team.
Develop, implement and manage all relevant Standard Operating Procedures (SOPs) and other procedures as needed for the uniformity and quality of operations. Ensure development, approval and achievement of department budget.
Ensures development, approval and achievement of department budget.
Work effectively to maintain interdepartmental cooperation and respect.
Assist in development and achievement of organizational and departmental goals consistent with CBC/CTS’s mission and strategic plan.
Provide leadership for CTS Manufacturing processes to integrate the needs of CTS customers and regulatory bodies. Processes include:
Production Planning and Inventory Management
Tissue Processing operations
Lot Processing operations
Medical Device regulations
Implement processes for continuous improvement and maximization of yield.
Oversee internal and external resources for the transfer of product design to manufacturing.
Ensure department employees are effectively interviewed, hired, trained, evaluated, developed, counseled, and disciplined to meet inventory needs, contract obligations and specifications.
Establish personal and operational goals for self and staff, setting performance standards and enabling professional development. Ensure timely accomplishment of goals.
Oversee Manufacturing procedures, reports and activities to insure a high degree of accuracy and identify areas for process improvement.
In association with the Executive Director of Manufacturing, monitor the changing external and internal environments and develop long term plans for CTS Manufacturing.
Perform other duties as assigned.
We offer a highly competitive benefit package including medical, vision, dental, life and supplemental insurance options, 401(k) with employer contribution and match, tuition assistance and generous paid time off (PTO).
Community Blood Center/Community Tissue Services is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.
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• Must have a minimum of ten years of progressive leadership experience in a manufacturing setting, medical device or biologic manufacturing environment preferred.
• Must have experience in LEAN manufacturing and/or some form of manufacturing improvement process.
• Must be well versed in current Good Manufacturing Practices, medical device manufacturing preferred.
• Must have experience managing external suppliers and development partners.
• Experience leading turnaround in a manufacturing process to improve processes and productivity is strongly preferred.
• Strong knowledge of domestic and international medical device standards and quality management systems (ISO 13485) preferred.
Knowledge, Skills and Abilities • Must be an ambitious leader with outstanding communication skills, focused on inspiring excellence and driving execution of process improvement ideas and goals.
• Must be highly organized, and possess keen problem solving and decision making abilities. .
Work Environment and Physical Activities • Must be able to work around high magnet circuits or magnetic fields.
• When working in the Core, will require extensive standing.
• Must be able to meet the required physical demands with or without reasonable accommodation.
Internal Number: 18-0147
About Community Tissue Services
Community Tissue Services (CTS) is the largest nonprofit provider of skin grafts to surgeons for severe burn patients in the United States. We strive to be on the forefront of new graft development and biotechnology to better serve recipients and medical professionals. CTS is a quality, ethical provider of services to donor families, medical communities, recipients, and community partners through recovery, processing, and distribution of tissue grafts.