Senior Process Engineer, Viral Vector, Upstream

AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer for Viral Vector U pstream Process Development. 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 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 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-for-purpose 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.

• Education :
  PhD in Chemical/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. Title will be commensurate with qualifications and experience.

• Experience :
  Hands-on 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, single-use rocking-platform and stirred-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 in cross-functional, matrixed teams; demonstrated problem solving and troubleshooting capability.

• Tools & Automation :
  Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.

• 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.

At AstraZeneca, we are…