Senior Director of Manufacturing (Durham)
Insight Global, Durham, North Carolina, United States, 27703
Requirements:
Bachelor’s Degree in a related scientific or engineering discipline
18+ years of experience in the biopharmaceutical industry
Broad based knowledge of upstream and downstream processing techniques and equipment
Experience with technical transfer
Experience working in a cGMP manufacturing environment
Job Description: Insight Global is seeking a Senior Director of Manufacturing for a biopharmaceutical in the RTP area. The Sr. Director, Manufacturing, oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost objectives. Responsibilities: Oversees hiring, training, and performance management for all Manufacturing staff. Develops an engaged and high-performing team. Provides clear direction and balanced performance feedback by coaching, developing, and challenging direct reports. As necessary, takes timely corrective action in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate. Serves as a mentor in developing direct reports and other leaders across the site. Serves as a role model for KBI’s Values. Directs department managers and monitors performance against manufacturing goals consistent with established manufacturing and safety procedures. Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results. Supports achievement of optimum employee headcount while minimizing overhead and raw material costs to meet annual budgetary plan and client budgets. Manages the establishment of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. Assists managers, supervisors, and other senior staff members in the development and formulation of long and short-range plans, policies, programs, and objectives. Identifies, recommends, and implements changes to improve productivity and reduce cost and waste. May lead major projects needed to add capabilities or manufacturing capacity, e.g., workstream lead. Serves as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Makes decisions as an SME on large-scale production processes. Performs miscellaneous duties and projects as assigned and required.
Job Description: Insight Global is seeking a Senior Director of Manufacturing for a biopharmaceutical in the RTP area. The Sr. Director, Manufacturing, oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost objectives. Responsibilities: Oversees hiring, training, and performance management for all Manufacturing staff. Develops an engaged and high-performing team. Provides clear direction and balanced performance feedback by coaching, developing, and challenging direct reports. As necessary, takes timely corrective action in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate. Serves as a mentor in developing direct reports and other leaders across the site. Serves as a role model for KBI’s Values. Directs department managers and monitors performance against manufacturing goals consistent with established manufacturing and safety procedures. Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results. Supports achievement of optimum employee headcount while minimizing overhead and raw material costs to meet annual budgetary plan and client budgets. Manages the establishment of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. Assists managers, supervisors, and other senior staff members in the development and formulation of long and short-range plans, policies, programs, and objectives. Identifies, recommends, and implements changes to improve productivity and reduce cost and waste. May lead major projects needed to add capabilities or manufacturing capacity, e.g., workstream lead. Serves as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Makes decisions as an SME on large-scale production processes. Performs miscellaneous duties and projects as assigned and required.