Cell Therapy Manufacturing Supervisor

NantKwest - El Segundo, CA (30+ days ago)3.2


The Manufacturing Supervisor will play a critical role as the primary point of contact for manufacturing, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and leading with minimal supervision. As a team member of the cell culture group you will work to support cell and tissue culture activities.

The manufacturing skills and training include expertise in mammalian cell culture, bioreactor process, aseptic technique, cell culture techniques, sterile media preparation, and clean room maintenance.

Essential Functions:
Bioreactor culture manufacturing including fed-batch, and perfusion with both stainless and single use cell culture technologies
Supervise operations of manufacturing facility in a cGMP environment
Demonstrated ability in cGMP bioprocess operations, particularly upstream processes and aseptic technique
Facilitate/lead technology transfers from Process Development and participate in the CMO interface as required
Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
Generate SOPs, MBRs, and EOPs for equipment and procedures used in routine biologics manufacture
Knowledge of cGMP guidelines or other good documentation processes
Execute production and resource schedule against operational plan
Ensure performance of all process steps specific to manufacturing (e.g. upstream, packaging, shipping, support)
Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
Complete the final review of completed manufacturing documentation per compliance standards and established timelines
Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
Interact with outside vendors and senior management
Collaborate within department and cross-functionally to meet set objectives
Take corrective action to bring about required changes using change control procedures

Educational/Experince Requirements:
BS in chemical engineering, genetics, molecular biology, microbiology, biochemistry, or a related field
Five (5)+ years of relevant industry experience or MS with relevant research experience
Proven track record of running a cGMP facility
Extensive experience running manufacturing-scale bioreactors including setup, sampling, troubleshooting hardware and software
A proven track record of accomplishments and timely delivery on goals
Knowledge of mammalian cell culture and physiology
Experience in aseptic processing, and cGMP manufacturing a plus
Is well-versed in manufacturing and production, especially in the area of biologicals
Complex Problem Solving: Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions
Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one
Speaking: Presenting to others to convey information professional and effectively
Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense
Available to work a flexible schedule, including occasionally coming in nights and weekends to support sampling of critical processes
NantKwest is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases and inflammatory diseases.