The upstream manufacturing supervisor will lead associates during the startup and production in the cell culture areas for a new clinical GMP biopharmaceutical facility.  The supervisor will coach associates during the commissioning, qualification, and production activities while safeguarding work environments and ensuring cGMP compliant behaviors.

Upstream supervisors will assign and supervise daily tasks of team members and maintain strict accordance with production batch records, SOPs and Good Manufacturing Practices. This proven and qualified candidate will use their past experiences, depth and knowledge of cell culture fundamentals in media preparation, seed expansion, bioreactor operations and cell culture harvest operations to teach, troubleshoot and continuously improve the daily operations of upstream manufacturing.
The supervisor should have in depth knowledge of incubators, biosafety cabinets, aseptic technique, bioreactors, filtration, cell counters, blood gas analyzers, metabolite testing equipment, and other general biotechnology auxiliary equipment such as filter integrity testers, balances, pumps, sterile tubing welders, tubing sealers, pH meters, and conductivity meters.  Experience using single use equipment is desired.  The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

The supervisor will review and understand manufacturing procedures and apply their fundamental knowledge combined with production batch records to train manufacturing personnel ensuring manufacturing operations are conducted accurately, safely and compliantly. 
The supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the supervisor will review the executed production batch records, and ERP orders to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes.

The ideal candidate can demonstrate that they have learning agility, are action oriented, drive for results, are excellent team workers, have a strong attention to detail, and have superior integrity and accountability. The incumbent will lead manufacturing planning and operations with a drive to ensure ‘Right the First time’ execution.
 

• Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution.  Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
• Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders.  Ensure timely corrections to batch documentation and logbooks. 
• Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees.  Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
• Author, train, review manufacturing procedures

Level Minimum Requirement

Supervisor H.S Diploma or Equivalent and 13+ years of relevant experience or B.A./B.S. in a Life Sciences or Engineering degree and 7+ years relevant experience or equivalent education and experience. 

Sr. Supervisor H.S Diploma or Equivalent and 15+ years of relevant experience or B.A./B.S. in a Life Sciences or Engineering degree and 9+ years relevant experience or equivalent education and experience. 

• Demonstrated knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred.
• Prior experience in a lead/leadership roll is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Fluent in French, with technical English language both reading and writing.
• Computer Skills: MS Office, ERP, EDMS, production equipment software, other
• Equipment Use: 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