The downstream manufacturing supervisor will lead associates during the startup and production in the purification 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.
Downstream 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 purification fundamentals in chromatography, filtration, viral inactivation and bulk fill operations to teach, troubleshoot and continuously improve the daily operations of downstream manufacturing.
The supervisor should have in depth knowledge of mixing vessels, chromatography equipment filtration equipment, protein concentration analytical measurement equipment, and other general biotechnology auxiliary equipment such as balances, pumps, sterile tubing welders, tubing sealers, pH meters, filter integrity testers 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.
JOB RESPONSIBILITIES
MINIMUM REQUIREMENTS
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.