Position Summary We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment. The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness. Key Responsibilities Process development and characterization Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies. Drive implementation of closed-system operations and automation strategies to support scalability and compliance. Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines. Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums. Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters. Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding. PPQ, Tech Transfer & Manufacturing Readiness Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes. Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record. Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required). Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms. Regulatory Support Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements. Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing. Cross‑Functional Collaboration Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment. Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions. Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes. Required Qualifications Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience. Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation). Demonstrated experience with GMP operations and late‑stage / commercial readiness. Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels Experience with late‑stage development, process characterization, and PPQ principles for cell therapy processes. Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation. Experience working in GMP environments, including batch record execution or review, deviations, and investigations. Strong technical writing, data analysis, and problem‑solving skills. Preferred Qualifications Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes. Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors). Experience implementing closed, automated, or high‑throughput systems. Experience designing and executing DOE and multivariate data analysis for cell therapy processes. Experience with JMP or similar statistical analysis tools. Experience contributing to BLA/MAA submissions or regulatory interactions. Knowledge of control strategy development and risk assessment tools (e.g., FMEA). Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development. Key Competencies Strong experimental design and execution skills. Excellent cross‑functional communication and collaboration. Ability to operate effectively in fast‑paced, late‑stage development environments. Scientific curiosity, ownership mindset, and willingness to support manufacturing operations. The annual base pay for this position ranges from $96K to $144K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. # Cell Therapy Date Posted 12-Nov-2026 Closing Date 19-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Senior Process Engineer, Cell Therapy Process Development.

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