Process Engineer III
Job Description
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.
Job Description
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:
- 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
Preferred Qualifications:
- 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.
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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Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.