Senior Scientist, Viral Vector Process Development, Upstream

AstraZeneca is looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Upstream). 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 platforms at clinical 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 Biology, Virology, 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 stoker 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.

The annual base pay for this position ranges from $ – $. Base pay…