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Senior Process Engineer, Manufacturing Sciences & Technology

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

Arbeitsbeschreibung

Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T cell therapies for cancer treatment. As a Sr. Process Engineer for Manufacturing Sciences and Technology (MSAT), you will provide process science 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 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.  

Responsibilities (include but are not limited to):

  • Perform process support as process development representative for manufacturing site
    • Define content requirements for and author process and product impact assessments
    • Lead functional teams to perform root-cause investigations and resolve deviations
    • Develop and improve data-based process performance monitoring systems
    • Perform process data-driven 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
    • Create and lead deviation reduction initiatives
  • Lead continuous improvement initiatives with high complexity and impact to global manufacturing network, often impacting commercial license
  • Design studies, author protocols and reports, for process characterization and validation studies
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
  • Represent process development for global change management and process related CAPAs
  • Support regulatory inspections and lead projects for regulatory commitments
  • Act as sending or receiving unit lead for technology transfers and support new product introductions
  • Advanced understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes
  • Conducts technical and scientific training
  • Act as communication channel between global organizations and site operations
    • Bring development project proposals to global process development groups for support
    • Support implementation of global projects at site level

Requirements:

  • MS Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 6+ years of experience
  • BS with 8+ years of experience
  • HS Diploma with 12+ years of experience

Preferred Qualifications:

  • 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
  • Highly experienced 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
  • Mostly independent in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives
  • Experience 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
  • Knowledge of ERP systems implementation is desirable