Sr Process Engineer II
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
- PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biochemistry, Material Science, or a related discipline with 2+ years of pharmaceutical or biotech process development experience OR MS in a related discipline with 5+ years of relevant academic or industry experience.
- Strong computer skills with the ability to multitask, self‑organize, and manage competing priorities.
- Demonstrated project management experience.
- Self-motivated, accountable, and willing to take on temporary responsibilities outside the initial job scope.
- Collaborative, results‑oriented mindset with a positive attitude and resilience in overcoming challenges.
- Ability to thrive in a fast‑paced, dynamic environment with minimal direction and shifting priorities.
Nice To Haves
- Familiarity with pharmaceutical regulatory requirements, including those related to raw materials and single‑use systems.
- Hands‑on experience with cell culture techniques, including bioreactors, cell isolation, and laboratory equipment.
- Experience in aseptic processing, cell passaging, sampling, media formulation, reagent and vial management, and cryopreservation.
- Proficiency in statistical design of experiments (DOE).
- Strong scientific or engineering foundation in bioprocessing, scale‑up/scale‑out, hydrodynamics, mass transfer, and equipment design and control.
- Understanding of cell biology principles, including cell differentiation, phenotype markers, and metabolic pathways.
- Basic material science knowledge and material compatibility considerations in cell culture environments.
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 technical outcomes and risks to cross‑functional partners and risk assessment teams.
- Define raw material requirements, qualification strategies, and acceptance criteria to support technology transfer, commercial launch, and lifecycle management.
- Translate process, quality, and GMP requirements into raw material and component design specifications in collaboration with 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 to improve supply chain resiliency.
- Lead and support material FMEA, CCIT, Adventitious Agent, and Nitrosamine risk assessments to enable regulatory filings.
- Support technical investigations, supplier audits, and regulatory inspection responses.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
