Principal Process Engineer

Kite Pharma
Santa Monica, CA, United States
Nov 08, 2020
Required Education
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.

Basic Qualifications:

PhD with 8+ years of experience in Biochemical Engineering, Chemical Engineering, pharmaceutical manufacturing, technology transfer & process development or MS with 10+ years of experience OR

Bachelor's Degree with 12+years of experience in Biochemical Engineering, Chemical Engineering line with 10+ years of pharmaceutical manufacturing, technology transfer & process development experience.

Preferred Qualifications:

Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices

Mastery of scientific and engineering principles

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

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 Sign up to follow @KitePharma on Twitter at

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.



Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

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