Senior Scientist, Viral Vector Process Development, Upstream
AstraZenecaAbout the role
AstraZeneca is looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Upstream). 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: Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit forpurpose knowledge records.
Process Characterization & Control: Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, 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: PhD in Biology, Virology, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years. Title will be commensurate with qualifications and 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, singleuse
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