Senior Research Associate, Upstream Process Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 09, 2020
Ref
R0015165
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

This individual will be an integral member of the Upstream development of the viral vector programs at Kite. The individual will contribute to the development, scale up and technology transfer of the viral vector production with focus on viral vector cell culture development. These activities can include aseptic cell culture of viral vector suspension and adherent cell lines, scale-down model development and qualification, process optimization, robustness studies, and process characterization. Experience with both suspension and adherent formats are desired.

In addition this individual in collaboration with our technical operations group will support process technology transfer activities, due diligence and facility fit assessment for internal and external manufacturing facilities. The candidate will also support development of upstream technology platforms to integrate process, media and cell line development.

These roles and responsibilities will include aseptic cell culture of viral vector cell lines, transfection and selection of mammalian cells, cell cloning, and evaluation of clonal cell lines in scale-down models of the production system.

Key Responsibilities
  • Active member of the viral vector upstream team would design, plan and execute laboratory studies in order to support process development,characterization or process improvements
  • Perform hands on work in an adherent cell stack factories or suspension culture, cell culture expansion, viral vector productionas well as process scale up and implementation into GMP clinical production suites.
  • Write and review technical documentation
  • Participate and influence a cross-functional development team to advance production activities
  • Develop manufacturing processes for viral vector products and develop process improvements and efficiencies
  • Perform process analysis and trend process performance
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters


Required Skills:
  • Knowledge of suspension or adherent cell culture formats, scale-up and engineering principles (e.g. growth rates, specific consumption/production rates, bioreactor aspect ratios, power calculations, gas transfer, shear stress)
  • Hands on expertise in laboratory cell culture operations such as maintenance and growth of cells in both static and suspension modes. Previous experience in the development of high productivity and suitable vector cell lines is desired.
  • Demonstrated excellence in viral vector or cell culture process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
  • Build, operate, and troubleshoot bench top and pilot scale bioreactors; compile and analyze results
  • Excellent communication and presentation skills and aptitude for problem solving
  • Experience with the preparation of regulatory filings for US and external markets is desired
  • Candidate should be self-motivated, ambitious, organized, and collaborative
  • Understanding of GMP manufacturing
  • Act as an effective and committed team player


Qualifications:
  • 4+ years of experience with BS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
  • 3+ years of experience with MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
  • Previous experience with Cell therapy products, viral vector production in both adherent and suspension cell culture systems, transient transfection and/or stable cell lines is desired.
  • A previous track record of cultureprocess development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents.
  • Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with automation technologies is desired.
  • Practical experience of cGMP manufacturing operations and fluency of regulatory regulationsis desired
  • Ability to think critically, and demonstrate troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skillsare essential.
  • Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting.
  • High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.


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!

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.