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Senior Process Engineer, New Materials

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

Kite is seeking a highly motivated individual with process development, materials science, and polymer manufacturing experience to work on the Process Technology and Materials Development Team within Process Development.  As a Senior Process Engineer, you will evaluate new materials (reagents, single use materials, and device kits) for application to next generation cell therapy processes.  You will also work with external partners to guide the development and design of new materials and support their implementation into Clinical Manufacturing. 

Are you interested in performing risk analysis and project management to demonstrate feasibility of new materials on time and under budget? Come join us in our mission to cure cancer!!

Responsibilities (include but are not limited to):

  • Evolve and align cross-functionally the vision, strategy, approach, and procedures for material selection, evaluation, risk management, and Clinical Manufacturing implementation
  • Prioritize new materials based on business objectives and evaluate feasibility
  • Understand, communicate, and apply regulatory requirements in selection and testing of final container and in-process GMP manufacturing materials
  • Leverage experience with polymer manufacturing to support the development and design of new single use materials, and to support investigations with single-use material failures in the cell therapy manufacturing process
  • Complete material assessments, oversee lab studies to evaluate feasibility and mitigate risks, analyze results, communicate findings in reports and presentations, and maintain materials knowledge database
  • Lead raw material risk assessments
  • Support material extractables and leachables assessment projects
  • Write raw material user requirements and Clinical specifications
  • Interface cross-functionally with Process Design, MSAT, Manufacturing, Supplier Quality, Supply Chain, Quality, Regulatory, and external partners

Requirements:

  • PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent and 3+ years of relevant experience
  • Master's Degree in a related discipline and 5+ years of relevant experience
  • Bachelor's Degree in a related discipline with 7+ years related experience
  • High School Diploma with 11+ years of relevant experience

Additional Qualifications:

  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
  • Thorough knowledge of Biologics Process development is essential.  Cell therapy process development experience is highly desired
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
  • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, and commercial GMP manufacturing
  • Experience with evaluation of new technologies as applied to bioprocessing and cell therapy
  • Experience in materials science and evaluation of biocompatible materials (i.e. extractables and leachables)
  • Cell culture and aseptic processing experience
  • Experience with risk management methodology
  • Excellent presentation and communication skills
  • Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to think critically and have demonstrated troubleshooting and problem-solving skills
  • Ability to function efficiently and independently in a changing environment
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description