Sr Process Engineer

Sr Process Engineer I

United States - California - Santa Monica Process/Product Development & Operations Regular

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

• Lead and coordinate hands‑on process development (PD) and technology development activities, including laboratory study design, experimental execution, analytical sampling plans, and data interpretation.
• Communicate study outcomes to cross‑functional partners and risk assessment teams to support data‑driven decisions.
• Define raw material requirements, qualification strategies, and acceptance criteria to support technology transfer, commercial launch, and product lifecycle management.
• Translate process, quality, and GMP requirements into clear design and technical specifications for vendors and external partners.
• Perform Supplier Notification Assessments (SNAs), global project‑related raw material change assessments, and raw material deviation impact assessments.

• Develop, implement, and maintain Raw Material Lifecycle Management (LCM) strategies.
• Drive second‑source raw material initiatives and collaborate with internal stakeholders to improve supply chain robustness and resilience.
• Lead and support Material FMEA, Container Closure Integrity Testing (CCIT), Adventitious Agent, and Nitrosamine risk assessments in support of regulatory filings.
• Support deviation investigations, supplier audits, and regulatory inspection responses related to raw materials and consumables.
• Strong computer skills with the ability to multitask, self‑organize, and manage competing priorities.
• Demonstrated project management experience, including cross‑functional coordination.
• Self‑motivated, accountable, and willing to take on responsibilities outside the initial scope as business needs evolve.
• Collaborative, results‑oriented mindset with a positive attitude and resilience in overcoming technical and operational challenges.
• Ability to thrive in a fast‑paced environment with minimal direction and adapt quickly to changing priorities.

• Strong computer skills with the ability to multitask, self‑organize, and manage competing priorities.
• Demonstrated project management experience, including cross‑functional coordination.
• Self‑motivated, accountable, and willing to take on responsibilities outside the initial scope as business needs evolve.
• Collaborative, results‑oriented mindset with a positive attitude and resilience in overcoming technical and operational challenges.
• Ability to thrive in a fast‑paced environment with minimal direction and adapt quickly to changing priorities.

• BS in a related discipline with at least 6 years of experience in pharmaceutical or biotechnology process development

OR

• MS in a related discipline with at least 4 years of experience in pharmaceutical or biotechnology process development

• PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biochemistry, Materials Science, or a related discipline
• Familiarity with regulatory requirements applicable to pharmaceuticals and single‑use disposable systems.
• Hands‑on experience with cell culture techniques, including bioreactors, cell isolation, and use of standard laboratory equipment.
• Experience in aseptic processing, cell passaging, sampling, media formulation, reagent and vial management, and cryopreservation.
• Proficiency in statistical design of experiments (DoE) and data‑driven process optimization.
• Strong scientific and engineering foundation in bioprocessing, scale‑up/scale‑out, hydrodynamics, mass transfer, and equipment design and control.
• Understanding of cell biology principles,…