At NantKwest, our Senior Scientist Cell Therapy in Process & Manufacturing Sciences (P&MS), will be responsible for cell culture based experiments and data acquisition, working with allogeneic and autologous Natural Killer cells, primarily cultivated in cell suspension. This includes mammalian bioreactor operations, downstream purification, formulation, filling and cryopreservation, and general cell culture process development exercises at small and large scale in our lab and pilot plant.
The Senior Scientist main role is to conduct late-stage process development, scale-up and characterization activities on multiple manufacturing platform processes, including scale-up, as well as technical product support, and process improvements.
Training in biology, biochemical engineering, microbiology, or a related field is required. Advanced knowledge of cell culture techniques, bioreactor operations and Design of Experiment methodology (DoE) would be preferred, as well as knowledge of tech-transfer, GMP operations, and experience with preparation of cell therapy products.
At NantKwest, Process & Manufacturing Sciences is the #1 GO-TO team for CMC Operations in the areas of :
Late-stage Process Development and Process Characterization, as per ICH Q8 (R2)
Technology transfer and Process installation
Manufacturability assessment and Due Diligence
Process capability improvement and COGs reduction
Technical support & training on the shop floor
Process monitoring & control, Data science
Regulatory CMC submission and inspection supports
NantKwest is an innovative clinical-stage immunotherapy company focused on harnessing the power of Natural Killer (NK) cells to treat cancer, infectious diseases, and inflammatory diseases. NantKwest is a successful growth story, focused on delivering breakthrough cell and immunology therapies to unserved cancer patient communities. NantKwest's CMC Operations is an energized and talented team with a highly collaborative culture, centered on innovation and making it happen for our patients. Come join us!
Develop experimental strategy and plans required for the development of new processes or technologies, including IND-enabling studies
Supervise and conduct experimental work related to process characterization and process development utilizing advanced statistical tools and experimental designs
Develop and qualify representative scale-down models of the manufacturing process
Contribute to development of long-range plans for Manufacturing and CMC Operations
Learn, maintain and advance expertise in areas relevant to company's products and strategic goals
Compilation, Evaluation, and Presentation of experimental data in oral presentations and written technical reports.
Author technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites or process changes.
Facilitate Tech transfer activities, and provide technical support to manufacturing organizations
Maintain laboratory preparedness including responsibilities for the PM, calibration, and operations of laboratory equipment.
Maintain experimental records and compliance procedures according to applicable GxP.
Able to thrive in a highly interactive and team-based environment.
Support manufacturing process changes, process validation, troubleshooting and investigation evaluations, change control, and regulatory submissions.
M.S. with minimum of 8 years relevant working experience or Ph.D. with minimum of 3-5 years of relevant experience in Life Science, Biochemistry, Cell Biology, or related science.
Minimum five years of relevant experience, with emphasis in cell culture
Broad scientific knowledge and expertise of Chemistry, Biochemistry, Cell Biology and Microbiology
Sound background in large-scale processing and engineering fundamentals as applied to cell culture processes
Experience in the following areas preferred :
cell culture of Lymphocytes
culture of primary cells
small and larger scale cell culture systems
cell cryopreservation techniques
cell sorting and centrifugation
FACS and cell staining
current Good Manufacturing Practices
DoE and statistical modeling
Ability to compile, analyze, and present data in oral and written forms.
Ability to manage external partners and vendors
Excellent interpersonal skills, proactive communication skills, strong written and verbal communication and presentation skills, and an ability to work effectively across diverse and cross-functional teams while balancing the needs of internal customers is required.
Strong initiative, problem solving, attention to detail, ability to effectively organize and prioritize are required.
Weekend and holiday work will occasionally be required on a rotating basis.
All hires are based upon successful completion of background check