Process Engineer II - Lab Support

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!

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