Senior Process Engineer, Viral Vector, Upstream — US - Gaithersburg - MD

AstraZeneca is looking for a highly motivated and experienced   Senior   Process Engineer   for   Viral Vector   U pstream   Process Development . The candidate will play a critical role in building and leading a high-performing   team   that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. You   will design, execute, and   optimize   upstream Lentiviral Vector (LVV) processes with a primary focus on  suspension   bioreactor platforms at clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through   IND enabling , partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs.   This position is based in Gaithersburg, MD.    Key Responsibilities   • Upstream Process Development : Plan and perform experiments to develop and   optimize   LVV upstream processes for  suspension   cell culture  (transient or   stable   producer cell systems), targeting improvements in   titer , quality, robustness, and cost.   • Bioreactor Operations & Scale Translation : Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.   • Experimental Design & Data Analysis : Develop DOE studies,   identify   CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain   fit- for- purpose   knowledge records.   • Process Characterization & Control : Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive solving, root cause analysis, and corrective actions.   • Tech Transfer & GMP Interface : Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with  cGMP  principles for late-stage readiness.   • Cross-Functional Collaboration : Work closely with Analytical Development on assay readiness and   in- process   testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.   • Operational Excellence : Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time,   right- first- time ) and recommend improvements.   Qualifications   • Education : Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience. • • Experience : Handson experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.  • Technical Skills :   Proficiency   in suspension cell culture, transfection/infection strategies, media/feed optimization,   single use   rocking-platform and   stirred-tank bioreactors, and upstream–harvest interfaces; working knowledge of statistical DOE and data analytics tools.   • GMP Readiness : Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.   • Communication & Teamwork : Strong written and verbal communication skills; ability to work effectively in   cross functional , matrixed teams; problem solving   and troubleshooting capability.   • Tools & Automation : Experience with   single- use   systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.   Preferred Qualifications   • Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.   • Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.   • Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.   • Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.     At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly evolving markets by continuously seeking innovative ways to deliver medicines to patients. Our team is diverse and connected globally, working together to push the boundaries of supply chain excellence. With a focus on sustainability and a dedication to doing things the right way, we offer opportunities for growth and development in a supportive environment. Join us in making a difference—apply today!   The annual base pay (or hourly rate of compensation) for this position ranges from $112,304.00 - 168,456.00. Our positions offer eligibility for various 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. Date Posted 16-Sep-2026 Closing Date 15-Sep-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.