Senior Process Engineer, Viral Vector, Upstream
Listed on 2026-09-25
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Engineering
Validation Engineer, Process Engineer
AstraZeneca is looking for a highly motivated and experienced
Senior
Process Engineer for Viral Vector Upstream Process Development. The candidate will play a critical role in building and leading a high-performingteamthat accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. Youwill design, execute, andoptimizeupstream Lentiviral Vector (LVV) processes with a primary focus onsuspensionbioreactor platformsatclinical 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.
Upstream Process Development
:
Plan and perform experiments to develop andoptimizeLVV upstream processes forsuspensioncell culture(transient orstableproducer cell systems), targeting improvements intiter, 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 usescale-down modelsfor characterization and comparability.
Experimental Design & Data Analysis
:
Develop DOE studies,identifyCPPs/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 withcGMPprinciples for late-stage readiness.
Cross-Functional Collaboration
:
Work closely with Analytical Development on assay readiness and
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