Sr Process Engineer I

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. As a Sr. Process 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)
• Prepares regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.
• Support digitalization and data automation projects.
• Analyze and identifies risks with processes, technologies and methods, creates a working plan to prevent potential issues.
• Liaise with manufacturing groups to deliver new and improved drug products.
• Work flexible hours for the coverage of the production facility.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 7 years of relevant work experience or
• MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology with 5 years of relevant work experience or
• HS Diploma with 11 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology
• Cell therapy experience is a plus.

Additional Qualifications:

• Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Demonstrated advanced 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 is a plus
• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment
• 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

Does this sound like you? If so, please apply today!
 

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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.