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Senior Engineer I, Manufaturing Science & Technology (MSAT)

Employer
Kite Pharma
Location
El Segundo, CA, United States
Start date
Oct 20, 2020

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Discipline
Engineering, Process Engineer
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 culture experience to work on innovative T cell therapy for cancer treatment. As a Sr. Engineer I for Manufacturing Sciences and Technology (MSAT) you will provide process engineering support for technology transfers, process and product comparability, process validations and GMP manufacturing for Kite's engineered T cell therapy products. Additionally, you will write product impact assessments, root-cause analysis reports, sampling plans, technical 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.

Key responsibilities:
  • Work closely with process design teams to assure process reliability and robustness in preparation for comparability and process validation.
  • Prepare and conduct initial training for process improvements and new process introduction.
  • Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
  • Participate and report to a cross-functional team to advance production activities.
  • Participate in Operational Excellence activities within Tier Structure.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
  • Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process and cell therapy manufacturing process validation testing)
  • Work flexible hours for the coverage of the production facility.
  • Other duties as assigned.


Basic Qualifications:
  • Bachelors degree in Biochemical Engineering, Biotechnology or Life Sciences with 7+ years of biotech experience.
  • Masters degree in Biochemical Engineering, Biotechnology or Life Sciences with 5+ years of biotech experience.


Preferred Qualifications:
  • Cell therapy experience
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Experience in statistical analysis using JMP or Minitab
  • Knowledge of data management tools and statistical process controls
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability


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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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.

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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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