About this opportunity
AstraZeneca GmbH lists this Senior Process Engineer, Viral Vector, Upstream opportunity in gaithersburg, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
Job description
AstraZeneca is looking for a highly motivated and experiencedSeniorProcess EngineerforViral VectorUpstreamProcess 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 throughIND 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 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; maintainfit- for-purposeknowledge 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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Worksite address
gaithersburg, MD, 20883, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.