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.
This Senior Scientist, Process Development will perform process development for autologous and allogenic cell therapy based processes and will be responsible for developing upstream and downstream manufacturing processes for cell therapy products. Areas of focus include Leukapheresis, cell enrichment, cell culture, recovery, formulation, fill-finish, and all aspects of cryopreservation including freezing, storage and thawing. The candidate’s primary responsibilities will include leading and participating in the design of experiments, executing the planned experiments, and optimizing the process steps to the target process scale. This will include laboratory and occasional pilot-scale scale bioreactors. The candidate will lead the design and execution of development studies to identify and determine appropriate ranges of (critical) process parameters for cell culture, to optimize growth and product production. The candidate will record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and also draft technical documents and perform technology transfer to collaboration partners. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives.
- Builds in depth process understanding by evaluating the effects of cell culture medium components and bioreactor process parameters on process performance, product quality attributes and cell metabolism.
- Develops robust process via design of experiments, execution of planned experiments, and optimizing the process steps to the target process scale. This will include laboratory and pilot-scale scale bioreactors.
- Design and execute development studies to identify and determine appropriate ranges of (critical) process parameters for cell culture, to optimize growth and high quality product generation.
- Lead the tech transfer of robust, efficient, and scalable cell culture processes to clinical and commercial manufacturing facilities.
- Requires demonstrated competency in aseptic laboratory technique and the ability to design complex experiments and interpret data.
- Requires demonstrated effectiveness in collaborative projects, and ability to communicate effectively with scientists and management in a highly matrix organization.
- Ensures effective, high-quality, timely and appropriate documentation in laboratory notebooks and internal Scientific Reports;
- Authors CMC Regulatory Filings and responses to Regulatory questions; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, Project Team meetings, conferences) and publishes in peer-reviewed journals, as appropriate.
- Works with a cross-functional team to advance development of NK cell therapy products
EDUCATION AND POSITION REQUIREMENTS:
- PhD. or equivalent in the area of Chemical/Biochemical engineering, Cell Biology, Biochemistry, or Immunology–0 -5years of experience with PhD required. (Equivalent experience: MS degree with 7+ years).
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products
- Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Wave bioreactors
- Strong mammalian cell culture expertise plus knowledge pertaining to other heterologous expression systems
- Demonstrated proficiency in design of experiments and data trending analysis
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to work independently on projects with long-term goals, and also as part of an integrated group on various protein-based human pharmaceutical project teams
- Excellent oral and written communications skills
- Scale-up/ Scale-down of bioreactor processes
- Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams