Senior Process Engineer of Process Development

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 21, 2020
Ref
R0015405
Required Education
Masters Degree/MBA
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

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?

We are seeking a highly motivated individual with cell culture experience to join us as a Senior Process Engineer to work on innovative T cell therapy for cancer treatment in Kite's Santa Monica, CA facility. As a Senior Process Engineer (SPE), you will provide process development and engineering support for process automation, technology evaluation, technology development, and technology transfers for GMP manufacturing of Kite's engineered T cell therapy products. Additionally, the SPE will write and/or review user requirements, functional requirement specifications, equipment qualification protocols, process development study protocols and reports, and provide technical assessments, rationales and approval for engineering and process changes to meet regulatory requirements. The Incumbent will also work with the Process Development (PD), Manufacturing and Quality teams to craft and implement automated cell therapy processes and support automated equipment qualification, as well as draft documentation for regulatory filings to advance Kite's product portfolio.

Responsibilities of the Senior Process Engineer of Process Development include:
  • Project management and/or project leadership with hands-on experience in new product, technology, or equipment development and implementation
  • Work with multi-functionally across Technical Operations including: early stage development, process development, technology development, technology transfer, manufacturing (clinical and commercial), quality, finance, supply chain and program management
  • Translate business, technical, and regulatory requirements into systems-level solutions during evaluation, development and deployment of new process technologies
  • Collaborate closely with site and global partners to define, develop and deploy automated processing technologies including equipment, single-use disposables and processes
  • Lead and develop user requirements based on process, quality and fitness for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate Kite specific requirements into functional and design specifications
  • Lead hands-on activities that support PD and process characterization, including drafting procedures, execution of laboratory studies, authoring technical reports, and participating on multi-functional risk assessment teams
  • Design and execute process development studies to develop a detailed understanding of operating and performance parameters
  • Lead and participate in exploration of technology landscape and evaluation of new technology and process improvements for introduction into GMP manufacturing. Develop and maintain technology roadmaps for future implementation
  • Operationalize new process technology to ensure successful GMP manufacturing
  • Handle technical work streams with cross-functional stakeholders and external collaborators throughout entire project lifecycle, from conception to implementation
  • Define, manage, and communicate project timelines and risks
  • Maintain hands-on understanding on cell therapy bioprocessing techniques
  • Support onboarding and mentoring of new team members


Requirements:

MSc Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related field with 5+ years of pharmaceutical manufacturing, process automation & process development experience OR BS Degree within the aforementioned academic fields with 7+ years of the above-mentioned experience

Preferred Qualifications:
  • Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing, cell therapy products and process development
  • Pharmaceutical products GMP manufacturing experience
  • Consistent track record of leading and running multi-functional teams
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Cell culture or aseptic processing experience
  • Excellent interpersonal, verbal and written communication skills
  • Knowledge of data management tools and statistical process controls
  • 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!

#IND123

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.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.