Process Engineer II
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
We are looking for a motivated Process Engineer II to join our Life Operation team within the Manufacturing Science and Technology (MSAT) department. you will provide technical expertise for lab characterization, life cycle management of Kite’s engineered T cell therapy processes and products. Additionally, you will support cross-functional projects focused on continuous improvement and technology transfer. As well as writing product impact assessments, sampling plans and technical reports. You will work with the Manufacturing, Quality, and Process development teams to implement and scale-out cell therapy processes, support process validations, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.
This position requires a strong background in scientific understanding and CAR-T pharmaceutical manufacturing.
Responsibilities:
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Design and oversee development studies, author and review protocols, reports and technical documentation for process characterization and validation studies. Including, executing process development studies for continuous improvement projects, deviation root cause analysis and new pipeline introductions.
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Lead laboratory activities including new technology/equipment knowledge transfer, deep understanding of process performance, perform analytical studies and manufacturing related investigations.
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Lead and support the evaluation and implementation of continuous improvement projects, innovative technologies, and process automation, ensuring seamless implementation of new products and technologies in manufacturing.
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Strong understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes.
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Collaborate with technical and operational stakeholders to draft, review, and finalize compliance and GMP documentation with a focus on advanced technical writing.
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Author impact assessments and root cause analysis for complex deviations to maintain routine manufacturing operations and determine appropriate CAPA for manufacturing.
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Represent the site MSAT function in global change management initiatives if needed.
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Act as a Subject Matter Expert (SME) for defined stages of lifecycle management, ensuring product and process quality as well as compliance, and providing support during regulatory inspections.
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Deliver technical and scientific training.
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Contribute to MSAT's strategic objectives and provide mentorship to junior engineers, fostering their growth and development.
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4+ years of experience with BS degree in a relevant scientific discipline. Or 2+ years of experience with MS degree in a relevant scientific discipline. PhD degree in a relevant scientific discipline is a plus.
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Experience with pharmaceutical manufacturing, technology transfer & preferably process development.
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Ability to work in a fast-paced company environment with changing priorities.
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Ability to function efficiently and independently in a changing environment.
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Strong scientific and engineering background
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Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, molecular biology, immunology, virology, gene-editing, and cell therapy process development
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Hands on cell culture or aseptic processing experience is required, preferably hands on experience with analytical techniques,
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Practical experience with cGMP setting manufacturing and regulatory regulations is a plus.
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Previous experience with cell therapy products is a plus.
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Technical Expertise: Strong knowledge of cGMP compliance, root-cause analysis, process development, and life cycle management. Experience with molecular biology, immunology, and virology is highly desirable.
Skills:
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Strong scientific and analytical knowledge to lead lab studies. Advanced problem-solving skills with the ability to manage and develop solutions to complex technical challenges.
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Strong communication and interpersonal skills, with the ability to work cross- functionally.
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Strong skill in project management, quality systems, and risk management.
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Ability to work independently and manage multiple priorities in a fast-paced environment.
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Able to put lean principles and continuous improvement methodologies into practice.
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General knowledge in digitalization and data automation tools.
Join us in this impactful role and be a driving force in the development and optimization of cutting-edge pharmaceutical products. If you're passionate about innovation, quality, and improving patient outcomes, we want to hear from you!
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 .
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.