*Director, Manufacturing Readiness and Compliance

Job Summary

The purpose of General Manufacturing Support is to drive long term development of manufacturing business and operational processes improving performance and predictability across the organization

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Responsible for Strategy development future outlook, target setting and roadmaps for short- and long term priorities within manufacturing
• Accountable for the Master Production planning – Near and long term capacity ownership, planning and scheduling
• The unit will be monitoring trends and improvements to drive Operational Excellence in Manufacturing with the aim of streamlining and optimizing procedures and ways of working across Manufacturing Readiness and Compliance and the three value streams.
• The unit will anchor improvements and learning by establishing NT/LT strategies, roadmaps, standardized processes, standards and templates and tools covering strategic, tactical and operational levels.
• Responsible for reporting to leadership on GMP bioprocess operations in Manufacturing across departments; establishes processes and standards based on company policies and external requirements.
• Develop, monitor and improve compliance with company quality systems, safety procedures, and other company policies
• Determine workflow and staffing across departments to achieve department goals
• Define and lead process improvements to documentation to improve operations and reduce errors
• Train, coach, and mentor managers and associates on manufacturing functions and support processes
• Set goals and assess performance for the department
• Directs and controls the activities of the Manufacturing Readiness and Compliance ; may do so through first-line managers
• Provides strategic leadership and technical expertise for the successful management of the function
• Effectively cascades functional strategy and contributes to development of organizational policies
• Initiates and leads departmental or interdepartmental strategic initiatives
• Maintains overall responsibility for planning and implementing budget
• Responsible for development of manufacturing training strategies and long term roadmaps
• Responsible for driving the digitalization agenda, business analytics and implement new digital initiatives

LEADERSHIP SKILLS

• Exercises the ability to influence the opinions and decision-making of others internally at the executive level and externally within the industry
• Leads collaboration across the organization to meet a standard of excellence

QUALIFICATIONS

Required:

• BS/BA degree with 12+ years of industry experience, Master’s degree with 10+ years of industry experience, or PhD with 7+ years of industry experience. Equivalent education and experience may substitute for stated requirements
• Extensive previous managerial experience also required

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.