(Sr) Process Engineer - MSAT

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

We are looking for a motivated (Sr) Process Engineer to join our Life Cycle Engineering (LCE) team within the Manufacturing Science and Technology (MSAT) department.

In this role, you will provide technical expertise for pharmaceutical products, supporting cross-functional projects focused on continuous improvement and technology transfer.

This position requires a strong background in pharmaceutical manufacturing and offers the chance to collaborate with global teams to drive process optimization and ensure product quality in a fast-paced, evolving environment.

Responsibilities:

• 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.

• Advanced understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes.

• Act as primary contact on behalf of pillar for global organizations and site manufacturing, assisting in maintaining alignment and fostering operational excellence.

• 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.

• Provide process development support as a representative of MSAT for the manufacturing site.

• Collaborate with technical and operational stakeholders to draft, review, and finalize compliance and GMP documentation with a focus on advanced technical writing.

• Author impact assessments and root cause analysis for complex deviations to maintain routine manufacturing operations and determine appropriate CAPA for manufacturing.

• Represent the site MSAT function in global change management initiatives.

• Facilitate risk assessments and implement remediation measures to support manufacturing improvements.

• 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.

• Deliver technical and scientific training.

• Contribute to MSAT's strategic objectives and provide mentorship to junior engineers, fostering their growth and development.

• Serve as delegate for the manager during periods of absence, ensuring continuity in leadership and operations.

Requirements:

• Education: Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field. A Master's in a relevant discipline is a plus.

• Experience: Minimum of 5+ years of experience in a pharmaceutical operations or GMP environment with proven expertise in cell culture, cell therapy, and aseptic processing.

• 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:

• Advanced problem-solving skills with the ability to manage and develop solutions to complex technical challenges.

• Advanced communication and interpersonal skills, with the ability to work cross-functionally.

• Advanced skill in project management, quality systems, and risk management.

• Ability to work independently and manage multiple priorities in a fast-paced environment.

• Able to put lean principles and continuous improvement methodologies into practice.

• 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.