Senior Associate Scientist, Analytical Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 16, 2019
Ref
R0010116
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Kite Pharma is seeking a highly motivated individual with bioassay, flow cytometry and analytical development experience to work in Analytical Development, Process Development, on innovative T cell therapy for cancer treatment. The Senior Associate Scientist will be responsible for analytical characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method technology transfer to and from Kite contract vendors. You will also be responsible to plan and execute laboratory studies, analyze experimental data and carefully document resultant information. You will draft and review protocols and process development reports, and work with the Process Development, Research and Quality Control teams to design and execute cell therapy processes and participate in laboratory activities to support analytical and process development as well as the characterization of Kite's autologous T cell products.

Key Responsibilities (include but not limited to):
  • Design, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of autologous T cell therapies in Product Sciences
  • Execute routine testing for Analytical Services from established test methods and SOPs
  • Write, review and edit accurate technical, development and qualification reports
  • Train technical staff, assign duties, and review data
  • Develop experimental approaches using new analytical technologies
  • Maintain, calibrate and operate cell analytical equipment and instruments
  • Other duties as assigned


Requirements:
  • Advanced degree (M.S., Ph.D.) in Immunology, Cell Biology, or related discipline is preferred with 2+ years of industry experience
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process development
  • Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
  • Experience in analytical method development and qualification of mammalian cell-based potency assays including co-culture assays, cytotoxicity assays, and proliferation assays
  • Demonstrate advanced knowledge in T cell biology and T cell signaling pathways
  • Experience with flow cytometry, magnetic bead cell sorting, and plate-based immunoassays (e.g. ELISA, MSD, luminescence)
  • Experience with mammalian cell culture including primary T cells
  • Experience with gene and cellular therapy T cell products a plus
  • Experience with Good Documentation Practices
  • Excellent skills in Microsoft Office, data analysis software (e.g. Prism, JMP, FlowJo, FACSDiva, SoftMax Pro), and other applications
  • Ability to think critically and demonstrate troubleshooting and problem solving skills
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Excellent interpersonal, verbal and written communication skills
  • While most of the schedule will be during a standard work-week, there will be occasional weekend work required
  • Ability to lift over 30 lbs


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

#LI-MH1

#IND123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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