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Process Engineer, Cell Therapy - Process Design

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

***Bonus, Equity, Paid Shutdowns, 401k Match***

Kite is seeking a highly motivated individual with cell culture experience to develop the manufacturing processes for the innovative T cell therapies for cancer treatment. As an Associate Process Engineer 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:·

Key responsibilities:

·Hands-on lab work and collaboration on process design studies to support process development, optimization, characterization, and essential process improvements

· Perform process training for GMP clinical production

· Participate in 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, study plans, draft manufacturing batch records, technical reports, and summary reports

· Create slides and supporting data to communicate results to senior leadership

· Other collaboration and cross-functional activities as assigned

Basic Qualifications:

· MS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 0 years of pharmaceutical manufacturing, technology transfer & process development experience required

· BS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 2 years of pharmaceutical manufacturing, technology transfer & process development experience required 

Preferred Qualifications:

  • Demonstrated cell culture and aseptic technique experience is required, including basic cell culture, preparation of media, cell counting, managing reagents and cryopreservation
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills are required
  • Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description
  • 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, i.e., Research, Translational medicine, Process development, Manufacturing, MSAT in a fast pace, the dynamic team setting
  • Basic knowledge of Immunology and T-cell biology
  • Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Practical demonstration of hands-on process development, including using the statistical design of experiments
  • Experience with bioreactors
  • 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
  • Knowledge of data management tools and statistical process controls