*Director Microbial Manufacturing

Job Summary

Responsible for reporting to leadership on GMP bioprocess operations in Microbial Manufacturing across departments; establishes processes and standards based on company policies and external requirements.

Essential Job Duties/Responsibilities

• Develop, monitor and improve compliance with company quality systems, safety procedures, and other company policies
• Determine workflow and staffing across the microbial manufacturing department to achieve production goals
• Recommend and operationalize GMP manufacturing process changes, output goals and quality requirements
• Define and lead process improvements (and related documentation requirements) to improve operations and reduce errors
• Train, coach, and mentor managers and associates on manufacturing functions
• Set goals and assess performance for the department
• Directs and controls the activities of the microbial manufacturing department, including 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

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.