Senior Director of Manufacturing
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.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.
- 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