KBI Biopharma Inc.
Senior Director, Manufacturing
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
Senior Director, Manufacturing
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 include: 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 correction action in accordance with company policy. Ensures compliance with current federal, state, and local regulations. 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 a SME on large-scale production processes. Performs miscellaneous duties and projects as assigned and required. Minimum Requirements Bachelor’s degree in a related scientific or engineering discipline with 18+ years biopharmaceutical industry experience and/or training; or equivalent Broad based knowledge of upstream and downstream processing techniques and equipment. Experience with technical transfer is desired. Experience working in a cGMP manufacturing environment is required. Language Ability Fluent in reading and writing the English language. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to perform process calculations to complete technical transfer analysis including but not limited to mass balances, cycle analysis, feed rate calculations, ratio determinations, and step yields. Computer Skills MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software Equipment Use Upstream and downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. WORKING CONDITIONS While performing the duties of this job, the employee is maybe exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; toxic or caustic chemicals; and risk of electrical shock.
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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 include: 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 correction action in accordance with company policy. Ensures compliance with current federal, state, and local regulations. 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 a SME on large-scale production processes. Performs miscellaneous duties and projects as assigned and required. Minimum Requirements Bachelor’s degree in a related scientific or engineering discipline with 18+ years biopharmaceutical industry experience and/or training; or equivalent Broad based knowledge of upstream and downstream processing techniques and equipment. Experience with technical transfer is desired. Experience working in a cGMP manufacturing environment is required. Language Ability Fluent in reading and writing the English language. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to perform process calculations to complete technical transfer analysis including but not limited to mass balances, cycle analysis, feed rate calculations, ratio determinations, and step yields. Computer Skills MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software Equipment Use Upstream and downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. WORKING CONDITIONS While performing the duties of this job, the employee is maybe exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; toxic or caustic chemicals; and risk of electrical shock.
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