Process Engineer, Process Technology and Materials Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 22, 2020
Ref
R0015467
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

Kite is seeking a highly motivated individual who's detail-oriented and thorough with cell culture experience to work on innovative T cell therapies for cancer treatment. As a Process Engineer I, you will be responsible for designing and executing engineering activities and lab studies in support of process automation, technology development, technology evaluation, equipment qualification, process validation, and GMP manufacturing. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings. You will work within the process technology and materials development team to design and scale-out cell therapy processes, evaluate new materials, implement innovative solutions, and support or improve existing technologies to advance Kite's product portfolio. You will work closely with analytical, process design, validation, manufacturing sciences, operations, business strategy, and external collaborators as needed to achieve the above objectives.

Key responsibilities:
  • Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.
  • Perform hands-on lab-based activities in a cell culture lab, including conception of study designs, analysis of data and communication of results to cross-functional project teams.
  • Perform process or equipment analysis and trend process or equipment performance.
  • Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
  • Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
  • Provide process training to GMP manufacturing personnel.
  • Support technology transfer and GMP manufacturing operations as needed.
  • Perform statistical analysis including design of experiments (DOEs) as appropriate.
  • Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
  • Support qualification, risk assessment, and validation activities as technologies advance closer to deployment at GMP clinical and/or commercial manufacturing.
  • Create and present slides with supporting data to communicate results to senior leadership or external collaborators.


Basic Qualifications:
  • Bachelors degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & 2+ years of process development experience.
  • Masters degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & 1+ year of process development experience.


Preferred Qualifications:
  • Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
  • Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
  • Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments.
  • Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals.
  • Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
  • Knowledge of material science and material compatibility for cell culture applications
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
  • 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 a fast pace dynamic cross-functional team setting across research, development, and manufacturing departments.
  • GMP manufacturing of pharmaceutical products.
  • Cell culture aseptic processing, experience with cell therapy products.
  • Use of principles and concepts of Lean Six Sigma or design of experiments to improve process capability.
  • Statistical analysis using JMP or Minitab.
  • Proven track record of working within cross functional teams.
  • Knowledge of data management tools and statistical process controls.
  • Experience performing process design and process automation.
  • Experience interpreting blueprints, PFDs, P&IDs, AutoCAD, PLC, and creating process flow maps.


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.