The Technical Director is responsible for our blood donor testing laboratory, blood components manufacturing, phase 3 clinical trial research and biomanufacturing, immunohematology reference lab, and providing technical guidance to donor services when needed. Must provide effective leadership to over 25 team members. Responsible for designing programs and tactics in line with company strategic goals, participating in senior leadership, assuring all processes and SOP are in compliance with state and federal regulations and AABB. Collaborates with Medical Director and other senior leaders to assure compliance, effectiveness, and positive culture within the company.
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Maintain fluent working knowledge of trends in our industry, best practices, and development that could pose opportunities or threats to our lab business.
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Talent Management- Oversees the recruiting, hiring, onboarding, professional development, and annual evaluation of leaders, and if necessary, termination.
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Coaches and mentors leaders to develop strong skills that facilitate the desired department culture and achievement outcomes
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In collaboration with Human Resources, oversee talent development planning for department, and identify strategies to support the team to be successful.
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In collaboration with the CCBC leadership team and human resources, revises organizational structure and human capital plans to optimize talent and meet department needs. Performs other duties as assigned.
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Supervisory responsibilities: The role oversees: (1) Assistant Director, (1) CLS Lead, (2) Lab Component Supervisors, and (25+) individual contributors.
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The ability to budget for the cost of laboratory operations considering supply cost, major equipment and projected staffing needs.
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Create and mentor a competent team of supervisors/managers/staff to assure exceptional department performance.
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Leads and directs all laboratory, component, and research personnel in all activities.
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Develop compliant processes and SOP’s adhering to Current Good Manufacturing Practices (cGMP).
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Directs, develops, monitors, and all staff training and competency procedures and activities.
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Maintains professional competencies appropriate for the position.
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Reviews all records, Quality Control, and Preventive Maintenance documentation to ensure compliance with FDA, AABB, and state regulations.
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Assures appropriateness of:
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All Laboratory SOP’s
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Training forms and records
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Preventative maintenance worksheets and forms
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Job Descriptions
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Staff compensation
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Monitor the discard and control of biohazardous waste.
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Direct all laboratory staff in preparing for inspections.
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Assures adherence to the Quality Plan.
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Demonstrates, mentors commitment to organizational collaboration.
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Demonstrate adherence to employee handbook and all company policies.
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Provide a representative for all appropriate committees and meetings; for example: Hospital Relations Committee, Quality Assurance Committee, BECS Committee, Medical Advisory Committee, Safety Committee, etc.
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Presents reports to President and others as directed.
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Assures confidentiality and integrity of all laboratory and organizational records.
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Adapts to organizational change.
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Accepts, develops, and incorporates new business and cost reductions.
