Principal Process Engineer

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 08, 2020
Ref
R0015672
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 with cell therapy validation experience to work on innovative T cell therapy for cancer treatment. As a Principal Engineer, Validation you will provide equipment qualification and process validation engineering support for technology transfers, new technology introductions, process and product comparability, process validations and GMP manufacturing for Kite's engineered autologous T cell therapy products. Additionally, you will write comparability and process validation project plans and protocols, sampling plans, production procedures, and process development reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements. You will work with Process Development, Manufacturing and Quality teams to design and scale-out cell therapy processes, define equipment qualification strategy and oversee process validation, as well as draft documentation for regulatory filings to advance Kite's product portfolio.

Key responsibilities:
  • Lead and define the strategy and implementation for comparability and process validation for new products, technology and/or process change introductions.
  • Lead and define performance qualification strategies for new technology introductions.
  • Work closely with process characterization teams to assure process reliability and robustness in preparation for comparability and process validation.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for equipment performance qualification and process validation.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
  • Work with vendors and suppliers to define requirements and understand functional specifications
  • Support investigations identify root causes for critical deviations during equipment qualification, process validation and determine CAPA for manufacturing.
  • Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing).
  • Participate on, report and communicate out to a cross-functional development team to advance production activities.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • Other duties as assigned.


Qualifications:
  • Bachelor's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with 10+ years of pharmaceutical manufacturing, technology transfer & process development experience. MS with 8+ years of experience or PhD with 2+ years of experience
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • 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
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills


Experience:
  • 10+ years of pharmaceutical manufacturing, technology transfer or process validation experience
  • Pharmaceutical products GMP manufacturing experience
  • Process validation experienced is preferred; Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is a plus.
  • Cell culture or aseptic processing experience is a plus
  • Previous experience with cell therapy products is a plus
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
  • Experience in statistical analysis using JMP or Minitab
  • Proven track record of leading and managing 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.