United States flag

Process Engineer II - Lab Support

United States - California - El SegundoProcess/Product Development & OperationsRegular

Job Description

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 biotechnology experience to work on innovative T cell therapies for cancer treatment. As a Process Engineer II for Manufacturing Sciences and Technology (MSAT), you will provide lab support for commercial GMP manufacturing, technology transfers, development studies, validation, and continuous improvement projects for Kite’s engineered T cell therapy products. Additionally, you will author product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering/ process changes. MSAT is currently building out a lab and this position will eventually transition into lab scientist position that will support deviation investigation and reduction.  

Responsibilities (include but are not limited to):

  • Perform lab support as the process development representative for manufacturing site
    • Author process and product impact assessments
    • Support cross functional teams to perform root-cause investigations and deviation resolution for moderately complex problems
    • Monitor process performance through data-based trending
    • Data based deviation resolution and improvement projects
    • Support manufacturing through risk assessments and remediation measures
    • Collaborating with technical and operational stakeholders, write and review SOPs, batch records, and other operational related documents as needed
  • Lead continuous improvement projects and support initiatives
  • Support development studies. Author protocols and reports for process efficiency studies
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
  • Support regulatory inspections and projects for regulatory commitments
  • Act as communication channel between global organizations and site manufacturing
  • Support building of new lab
  • Once the lab is built, the roles will expand to
    • Perform assay or tests for investigation of process/equipment/material issues.
    • Design and author experimental studies
    • Conducts technical and scientific training

Requirements:

  • BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 4+ years of relevant experience or
  • MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 2+ years of relevant experience or
  • HS Diploma with 6 + years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

  • Basic knowledge in analytical techniques (eg. Flow)
  • Demonstrates ability in executing assays or test and interpreting experimental outcomes
  • Have an understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Experience with leading investigations, writing deviation reports, change controls, and corrective actions
  • Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
  • Experience working with or leading cross functional teams to obtain project deliverables
  • Working knowledge of scientific and engineering principles
  • Knowledge of data management tools and statistical process controls
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

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

#LI-ML1
#MFG123MD