Senior Process Engineer, Upstream

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

The Process Development team at Kite Pharma is leading all the life cycle activities related to current commercial viral vector products, while establishing vector production platform capabilities to support the development of new cellular therapies. This position will be passionate about lifecycle management activities, such as risk assessment, design and execution of characterization studies, process improvements or site-specific requirements, which might be identified during technology transfer to clinical or commercial facilities. The person will also serve as the process development lead for technology transfer to ensure readiness of the process transfer knowledge package to the Manufacturing Science and Technology (MSAT) team and will provide process engineering support for technology transfers, process and product comparability.

Responsibilities and Duties

• Execute life cycle management activities encompassing process characterization, risk assessment and addressing technology transfer needs, providing technical expertise to establish normal operating ranges (NORs), assess process changes for product quality impact via the change control workflow while working cross functionally between Process Development and Manufacturing departments.
• Generate reports from process characterization studies that can be used for reference in technology transfer processes as well as in support of manufacturing deviations
• Work in collaboration with process design teams to assure process reliability and robustness in preparation for process and operational comparability between various sites, while meeting process validation needs.
• Work with quality and analytical team to lead and execute required long term and accelerated stability studies in support of the viral vector product or process intermediates.
• Draft and review regulatory filling documents in support of lifecycle management.
• Lead and coordinate the activities from the process development site (sending unit) in preparation of technology transfer to the receiving unit (Clinical/Commercial Manufacturing)
• Work with manufacturing and process design teams to define requirements and understand operational ranges and specifications for the new product introduction to the facility, which might feed into the new characterization study design.
• Use experience and work cross-functionally to provide resolution for technical challenges that may be encountered during technology transfer.
• Prepare and conduct initial training for the receiving unit staff in support of the technology transfer, process improvements or new process introduction.
• Review technical documentation (batch records, site SOPs, protocols and reports for equipment qualifications, comparability, process validation acceptance criteria, and viral vector manufacturing process validation).

Qualifications

• Degree in Biochemical Engineering, Biotechnology or Life Sciences with 5+ years of pharmaceutical manufacturing, technology transfer and process development experience required
• Practical expertise/knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics and Gene and Cell therapy products.
• Previous experience with definition and characterization of a late-stage process control strategy, process validation and commercial technology transfer is preferred.
• Extensive hands-on experience with upstream process development, media preparation, cell age studies and bioreactor scale up principles.
• Experience in statistical analysis using JMP or Minitab
• Mastery of scientific and engineering principles with strong scientific writing and presentation skills to clearly communicate to leadership or regulatory committee
• Ability to think critically, analytically and have proven troubleshooting and problem-solving skills based on deductive reasoning
• Highly collaborative teammate who demonstrates open communication. Function and contribute as part of a team and to team-based decisions

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

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.