Senior Process Engineer, Viral Vector, Upstream

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

AstraZeneca GmbH in Gaithersburg, MD seeks a highly motivated Senior Process Engineer to lead LVV upstream development for viral vector platforms, collaborating across research, development, and manufacturing.

You will design, execute, optimize processes, drive scale-up and tech transfer, and work with CDMOs and GMP interfaces to enable late-stage readiness.

Qualifications

• Design, execute and optimize LVV upstream processes for suspension cell culture.
• Contribute to experimental design, process characterization, and tech transfer.
• Partner with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality and CDMOs.

Responsibilities

• Plan and perform experiments to develop LVV upstream processes.
• Execute unit operations across seed, production, and harvest interfaces; support scale‑up strategies.
• Develop DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies.
• Contribute to design space, in-process controls, and operating ranges.
• Prepare technical transfer packages and support transfers to GMP sites and CDMOs.
• Cross-functional collaboration with Analytical Development.

Skills

Upstream process development

Bioreactor operations

DOE design of experiments

Data analysis

Process characterization

Tech transfer

Cross-functional collaboration

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