Senior Process Engineer, Viral Vector, Upstream

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 on suspensionbioreactor platforms at clinical 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 for suspensioncell 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 use scale-down models for characterization and comparability.

• Experimental Design & Data Analysis: Design DOE studies,identifyCPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintainfitforpurposeknowledge 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 andinprocesstesting; 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,rightfirsttime) and recommend improvements.

Qualifications

• Education: PhD inChemical/Biomedical Engineering,Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years.Titlewill becommensuratewith qualifications and experience.

• Experience: Handsonexperiencedeveloping suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.

• Technical Skills:Proficiencyin suspension cell culture, transfection/infection strategies, media/feed optimization,singleuserocking-platform andstirred-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 incrossfunctional, matrixed teams; demonstratedproblemsolvingand troubleshooting capability.

• Tools & Automation: Experience withsingleusesystems, 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.

The annual base pay for this position ranges from $97,372.00 - $146,058.00. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 changing markets by continuously seeking better 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 commitment 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!