NantKwest (NASDAQ: NK) is a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases. NK cells are the body’s first line of defense due to the innate ability of NK cells to rapidly identify and destroy cells under stress, such as cancer or virally-infected cells.

The Quality Control Microbiology Supervisor is responsible for overseeing the daily operations of the microbiology, including environmental and utilities monitoring testing programs and in-process and product release testing, to ensure compliance with cGMP standards by means of a hands on approach to laboratory operations. The supervisor will provide technical support with regard to method verification, Environmental Monitoring, Utilities and new technology.

The QC Supervisor will supervise a team of analysts and be responsible for all aspects of people management including training, time management and performance reviews. This role will be responsible as an SME on product testing and environmental monitoring with responsibility for OOS investigations and deviation writing, technical writing and schedule management for NantKwest. The incumbent will also play a critical role in working collaboratively with cell culture manufacturing management and associates and other business partners in support of lab scheduling. Important aspects of this role include excellent communication skills, organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and other duties may be assigned. Essential duties are performed with regular oversight of QC Senior Manager.

Responsibilities:

• Lead a team of analysts in QC by coordinating and participating (as needed) daily operations and ensuring tasks are complete to meet business needs.


• Management of QC Microbiology training program, including Aseptic process qualification and gown qualification programs. Include reporting.


• Management of QC Microbiology data, including verification/review of data, document control, reporting processes, monitor and trend analysis


• Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions. Troubleshoot laboratory methods and instrument problems.

Requirements:

• BS or BA in Microbiology or related discipline and 7+ years of relevant experience or MS in Microbiology or related discipline and 4 years of relevant experience


• Minimum of 2 years of supervisory experience.


• Minimum of 7+ years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.

Knowledge, Skills & Abilities

• Minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.


• High degree of technical competency in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product preferred


• Strong working knowledge of cGMP requirements and FDA guidance for biologics and cell therapy manufacturing


• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.


• Strong analytical and communication skills as well as sound judgment with th