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GENERAL SUMMARY OF POSITION:

The Senior Director, Manufacturing, is responsible for the planning and timely execution of all manufacturing projects for a cGMP regulated Biologics Research & Manufacturing facility. The Senior Director will assist in development departmental strategic plans and prioritize projects with an emphasis on continuous quality improvement. This is a performance based position where success is measured through the achievement of organizational and departmental goals.

MAJOR RESPONSIBILITIES:

• Directs the activities of Monoclonal Antibody manufacturing, Vaccines, and Supply Chain Departments, ensuring compliance with cGMP and other applicable regulations.
• Ensures that manufacturing efforts yield sufficient commercial and clinical trial product to fulfill customer needs and accomplish MBL organizational goals.
• Analyzes manufacturing capacity and efficiency; makes recommendations for efficiency improvement.
• Responsible to ensure that manufacturing activities are managed in accordance with available budget, resources, and personnel.
• Recommends proposals for deviations from budgets
• Submits project schedules and any deviation from schedules for approval. Manages root cause analysis of deviation from schedules
• Liaise with Regulatory and Quality Directors to builds consensus on approach to ensure that regulatory requirements are met before proceeding with manufacturing projects.
• Reviews and approves technical and regulatory reports, new SOP's and significant SOP revisions
• Negotiates vendor contracts on behalf of MBL. Ensures that vendors meet terms of negotiated contracts
• Hires, manages and trains staff. Plans and assigns projects to meet departmental and organizational objectives.
• Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance
• Maintains substantial current technical knowledge related to all procedures relevant to Monoclonal Antibody and vaccine manufacturing
• Work with the Process Development group to discuss implementation of new manufacturing processes and improvements to existing manufacturing processes.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a PhD and demonstrated senior leadership experience or 
• Bachelor's degree and 15 years experience including senior management experience.
• Prior Manufacturing Management experience within a cGMP regulated biotech or pharmaceutical company required
• Demonstrated ability to effectively manage others, manage performance, set and prioritize departmental goals
• Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines
• Excellent written and verbal communication skills
• Excellent customer service skills
• Experience in any of the following areas preferred:
• Manufacturing of Biologics
• Monoclonal antibody manufacturing experience preferred.
• May require frequent travel between the JP and Mattapan campuses