Oversees the management of all areas of Upstream manufacturing (media preparation, cell culture and harvest steps) and related Specialist support teams involved in producing drug substances with the aim of achieving schedule, quality and cost objectives.

JOB RESPONSIBILITIES 

• Lead Upstream staff hiring, oversee training and lead staff evaluations. Develop an engaged and high-performing team. Provide clear direction and balanced performance feedback; coach, develop, and challenge direct reports; Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current local regulations. Consults with Human Resources Department as appropriate
• Serve as a mentor in developing direct reports and other leaders across the site. Serve as a role model of KBI’s Values.
• Directs and monitors department supervisors in accomplishing 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.
• Support achieving optimum employee levels with least amount of 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, supervisor 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, etc.).
• Serve as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Make decisions as a SME on mammalian large scale production
• Perform miscellaneous duties and projects as assigned and required.

• Bachelor’s degree in a related scientific or engineering discipline and 7+ years industry experience (mammalian, cell culture or fermentation); or 10+ years related experience and/or training; or equivalent.
• Ideal candidate will have broad based knowledge of Upstream and Upstream processing techniques and equipment for mammalian cell culture processes using Disposable Technologies.
• Experience with technical transfer is desired.
• Experience working in a cGMP manufacturing environment is required.
• Experience working in a CDMO business environment is a plus
• Knowledge and experience operating or overseeing the use of  GMP manufacturing equipment such as: Biosafety Cabinets, Incubators, Single Use Bioreactors, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, Other lab equipment, other production equipment, and Office Equipment
• Computer Skills: MS Project, Visio, Word, E-mail, Excel, MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software
• Able to communicate by writing and fluent in English and French
• Shall be able to represent KBI during business meeting involving client’s program presentation and support Customer’s audits.