Senior Director, Manufacturing

Position Summary

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.

• 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.

• 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.

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.

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.

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.

MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software

Upstream and downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

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.

Salary range provided per current averages…