Associate Director, Viral Vector Process Development, Upstream

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 lead 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.

Key Responsibilities

• 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).

Qualifications

• 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.

Preferred Qualifications

• Clinical/Commercial Scale Delivery: Demonstrated success scaling suspension-based LVV processes to clinical and commercial production with sustained performance and continuous improvement.

• Analytical Interface: Familiarity with upstream–analytical linkages (titer, infectivity/potency, residuals/impurities) to guide process decisions and specifications; experience defining process controls for suspension systems.

• Regulatory Contributions: Experience preparing process/manufacturing sections of regulatory submissions and participating in health authority interactions for LVV programs.

• Operational Excellence: Track record implementing Lean practices and robust documentation/knowledge management in PD settings.

The annual base pay for this position ranges from $138,392.80 - $207,589.20.