Senior Research Associate, Process Design

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 26, 2020
Ref
R0015058
Required Education
Associate 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

Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. As a Senior Research Associate in Process Design, you will provide process development support for New INDs, technology transfers, process validations and GMP manufacturing for Kite's engineered autologous T cell therapy products. Additionally, you will draft and review protocols, production procedures, and process development reports. You will work with the Process Development team to design and scale-out cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance Kite's product portfolio.

Key responsibilities:
  • Hands on execute and collaborate on process design laboratory studies to support process development, optimization and characterization and essential process improvements.
  • Perform hands on work in a cell culture lab and process training for GMP clinical production.
  • Participate and influence a cross-functional development team to advance CMC activities
  • Perform process analysis and trend process performance
  • Develop manufacturing processes for cell therapy products
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters
  • Perform statistical analysis including design of experiments (DOEs) as appropriate
  • Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports and summary reports.
  • Create slides and supporting data to communicate results to senior leadership.
  • Other duties as assigned


Qualifications:
  • Demonstrated cell culture and aseptic processing experience is required including basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, and managing reagents.
  • Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
  • Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with bioreactors is desired.
  • Mastery of scientific and engineering principles


Skills:
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills are required.
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills
  • 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
  • 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, dynamic team setting


Experience:
  • Bachelors degree in Biochemical Engineering, Chemical Engineering, or related discipline with 2+ years of pharmaceutical manufacturing, technology transfer & process development experience required
  • Masters degree with 1+ year of experience
  • Pharmaceutical products GMP manufacturing experience is a must
  • Cell culture or aseptic processing experience is a plus
  • Previous experience with cell therapy products is a plus
  • Knowledge in immunotherapy and cancer cell therapy is a plus.
  • Basic understanding of cell therapy bioassays and test methods (Flow cytometry and qPCR) is a plus.
  • Understands and employs principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus
  • Experience in statistical analysis using JMP or Minitab
  • Proven track record of working within cross functional teams
  • Knowledge of data management tools and statistical process controls


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.