The fundamental role of the Director of Production (Cadaveric) is to collaborate on all aspects of developing, creating, implementing, and reviewing manufacturing initiatives in accordance with the company's Standard Operating Procedures and under the guidance of the Senior Director of Production and executive leadership.
Responsibilities
Provide strategic oversight and leadership for Cadaveric Tissue operations, ensuring seamless integration of new technologies and methodologies
Facilitate expansion and scaling of production operations to accommodate organizational growth, ensuring efficiency, cost-effectiveness, and adherence to production schedules
Execute long-term production strategies in collaboration with executive leadership to align with corporate goals
Refine production policies, processes, and operational frameworks that enhance scalability, compliance, and efficiency
Collaborate with Research and Development to transition product innovations into full-scale manufacturing, ensuring smooth integration into production workflows
Ensure compliance with regulatory requirements, including AATB, FDA, ISO, state, and local authorities, maintaining high quality and compliance standards
Manage and continuously develop a high-performing production leadership team, including Managers and Supervisors
Help regulate departmental budgeting, cost control, and financial planning to optimize resource allocation and maintain profitability
Lead workforce planning initiatives, ensuring adequate staffing, training, and development programs
Collaborate cross-functionally with Quality Assurance, Regulatory, Supply Chain, and other departments to drive alignment and operational excellence
Provide regular performance updates, production metrics, and strategic recommendations to executive leadership
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
Manage direct reports
Provide constructive feedback and guidance to develop leadership in direct reports and department management
Establish and monitor objective annual goals for direct reports
Conduct performance reviews and establish performance improvement plans as needed
Recruit, interview, and select personnel for hire
Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives
Maintain acceptable attendance and punctuality for scheduled work hours and meetings
Ensure completion of assigned tasks and responsibilities within defined timeframes
Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
Perform other duties as assigned
Skills
Ability to work independently and in a team environment
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate the right behaviors
Ability to multi-task and work in a fast-paced environment
Strong technical writing
Effective project management
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor's degree in sciences, finance, operations management, or business field from an accredited institution required
Minimum of 5 years of progressive leadership experience in manufacturing, and at least 5 years within the tissue manufacturing or biomedical industry
Experience in scaling operations and leading teams through growth phases, preferred
Strong background in regulatory compliance and quality systems in a manufacturing setting
Clearance of favorable background investigation required