Associate Director, Viral Vector Process Development, Upstream

Overview

AstraZeneca is looking for a highly motivated, experienced and strategic Associate Director, Viral Vector Process Development (Upstream). This role will be a key part of a high‑performing function that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. The role will lead end‑to‑end upstream design, development, and scale‑up of Lentiviral Vector (LVV) manufacturing processes, with a primary focus on suspension bioreactor platforms at clinical and commercial scales.

This leader will drive upstream process development strategy and execution from research through IND enabling and into late‑stage readiness. The role operates in a highly collaborative, matrixed environment. The ideal candidate combines deep viral vector expertise with operational excellence and cross‑functional leadership. This position is based in Gaithersburg, MD.

• Upstream Lead on Suspension Platforms:
  Lead platform and product specific LVV upstream processes optimized for suspension cell culture (e.g., stable producer or transient systems); drive innovations to improve titer, quality, robustness, and cost at pilot, clinical, and commercial scales.
• Scale‑Up, Scale‑Down, and Tech Transfer:
  Design scale‑up strategies from bench to 50–200 L single‑use bioreactors; establish representative scale‑down models for characterization and comparability; lead phase‑appropriate validation and technology transfer to internal GMP sites and CDMOs.
• Experimental Design & Characterization:
  Oversee design, planning, and execution of upstream studies; identify CPPs/CMAs and establish design space using statistical DOE, MVDA, and PAT; implement and maintain a fit‑for‑purpose knowledge management system capturing process history, lessons learned, and control strategies.
• Team Leadership:
  Provide mentoring, training, and technical guidance to the other junior team members; promote a culture of safety, scientific rigor, and continuous improvement.
• Documentation & Compliance:
  Ensure generation of high‑quality technical documentation (protocols, characterization reports, validation summaries, tech transfer packages, and regulatory CMC sections); implement fit‑for‑purpose systems and business processes aligned with corporate guidelines and cGMP principles for late‑stage readiness.
• Operational Excellence:
  Perform process performance trending, root cause analysis, and corrective/preventive actions; establish and track KPIs (titer, infectivity, impurity profiles, cycle time, right‑first‑time); deploy Lean and digital tools for scheduling, data integrity, and reproducibility.
• Stakeholder & Vendor Management:
  Collaborate with internal partners and external suppliers/CDMOs; support sourcing and qualification of single‑use suspension bioreactors, mixing systems, and critical raw materials (media, feeds, plasmids).

• Education:
  
  Advanced degree (PhD) in Biochemical Engineering, Virology, Chemical/Biomedical Engineering, Biotechnology, or related field with 6+ years of relevant experience; or MS with 10+ years.
• Experience:
  
  Deep expertise in upstream LVV process development on suspension platforms, including scale translation to clinical/commercial, process characterization, and technology transfer; proven track record advancing programs from research through IND enabling and into late‑stage/GMP settings.
• Technical
  
  Skills:
  
  Mastery of upstream unit operations for LVV in suspension (cell substrate selection and adaptation, transfection/infection strategies, media/feed optimization, bioreactor control, harvest/clarification interfaces) and application of statistical DOE and data analytics.
• GMP Readiness:
  Practical experience with cGMP manufacturing operations, phase‑appropriate validation, and contributing to regulatory filings for US and ex‑US markets.
• Leadership & Communication:
  Ability to lead teams, influence in a matrix environment, and communicate complex technical concepts to diverse stakeholders; strong troubleshooting and problem‑solving skills.
• Tools & Automation:
  Experience with single‑use suspension bioreactors, process automation, PAT, and digital lab systems to accelerate development and ensure reproducibility.