Process Engineer III

Kite Pharma•Santa Monica, CA

3d•Onsite

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 Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with at least 6 years of experience OR MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with pharmaceutical / biotechnology manufacturing & process development with at least 3 years of experience

Nice To Haves

Working experience on cell therapy platforms
Established cell culture lab techniques and aseptic processing in an laboratory such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments is required.
Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals.
Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
Knowledge of material science and material compatibility for cell culture applications
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
Ability to think critically, troubleshoot, and problem solve in a timely manner.
Excellent interpersonal, verbal and written communication skills are required.
Ability to function efficiently and independently in a changing environment.
Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.
Well-developed computer and data analysis skills.
High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Ability to work and collaborate in a fast pace dynamic cross-functional team setting across development, quality and manufacturing departments.

Responsibilities

Conduct cell therapy process development experiments using automated platforms.
Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.
Perform hands-on lab-based activities in a cell culture lab, including conception of study designs and analysis of data
Perform process or equipment analysis and trend process or equipment performance.
Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
Provide process training to GMP manufacturing personnel.
Support technology transfer and GMP manufacturing operations as needed.
Perform statistical analysis using software such as JMP, Minitab and perform design of experiments (DOEs) as appropriate.
Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
Create and present slides with supporting data to communicate results to stakeholders, cross-functional project teams, senior leadership or external collaborators.
Perform other duties as assigned.