Process Engineer II - Cell Therapy

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Kite is seeking a highly motivated and detail-oriented individual with process development experience to work on innovative T cell therapies for cancer treatment. The Process Engineer I or II will be responsible for designing and executing experiments in the lab, help process development, process characterization, technology transfer activities, support or improve existing technologies, implement innovative solutions in commercial, and clinical manufacturing to advance Kite's product portfolio. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings. Process Engineer I or II will work on Autologous Process Design and Development within the Life Cycle Management Team.

Key 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.

Basic Qualifications:

• MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with pharmaceutical / biotechnology manufacturing & process development with 2+ year of experience or

• BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 4+ years of experience or

• AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or

• High School diploma with 6+ years of pharmaceutical / biotechnology manufacturing & process development experience.

Additional Preferred Qualifications:

• Working experience on automated cell therapy platforms

• Established cell culture lab techniques and aseptic processing in an ISO 5 environment 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, deep sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.

• Well-developed computer skills.

• High energy level and a positive outlook coupled with a "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.

• Comfortable in a fast-moving 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 research, development, and manufacturing departments.

The salary range for this position is: $97,495.00 - $126,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

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.