Sr Process Engineer I

Kite Pharma • Santa Monica, CA

1d

About The Position

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. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Requirements

• 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
• 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.

Nice To Haves

• 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, including differentiation, phenotype markers, and metabolic pathways (preferred).
• Working knowledge of materials science, material compatibility, and interactions with cell culture systems (preferred).

Responsibilities

• 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 resiliency.
• 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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level