Process Engineer, Cell Therapy - Process Design

Kite Pharma, Inc. Santa Monica , CA 90405

Posted 3 weeks ago

For Current Kite Pharma Employees and Contractors:

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

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 OR
  • BS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 2 years of pharmaceutical manufacturing, technology transfer & process development experience OR
  • AS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 4 years of pharmaceutical manufacturing, technology transfer & process development experience OR
  • High School Diploma with 5 years of pharmaceutical manufacturing, technology transfer & process development experience

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

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.

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 contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.


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Process Engineer, Cell Therapy - Process Design

Kite Pharma, Inc.