Director, Viral Vector Process Development, Upstream

AstraZeneca is looking for a highly motivated, experienced and strategic Director, Viral Vector Process Development (Upstream). This role will build and lead 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 own upstream 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 Strategy on Suspension Platforms
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  Define and 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
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  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
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  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 & Capability Building
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  Build, lead, and develop a high‑performing upstream PD team with deep expertise in suspension bioreactor operations; provide mentoring, training, and technical guidance; promote a culture of safety, scientific rigor, and continuous improvement.
• Cross‑Functional Program Execution
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  Represent upstream PD on program teams; drive timelines, resources, risk management, and decision‑making to meet aggressive milestones; contribute to CMC strategy, control strategy definition, and regulatory interactions.
• Documentation & Compliance
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  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
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  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
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  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
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  Advanced degree (PhD) in Biochemical Engineering, Virology, Chemical/Biomedical Engineering, Biotechnology, or related field with 8+ years of relevant experience; or MS with 10+ years.
• Experience
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  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
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  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
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  Practical experience with cGMP manufacturing operations, phase‑appropriate validation, and contributing to regulatory filings for US and ex‑US markets.
• Leadership & Communication
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  Ability to…