Associate Director, Viral Vector Downstream Process Development

AstraZeneca seeks an Associate Principal Scientist to lead lentiviral vector downstream process development from early stages through commercial manufacturing. The role requires extensive expertise in viral vector purification, process scale-up, and regulatory strategy within a matrixed, cross-functional environment.

Responsibilities

• Define and execute end-to-end lentiviral vector purification strategies aligned with phase-appropriate development from IND through commercial manufacturing
• Lead cross-functional matrixed teams, provide technical oversight, and mentor scientists and engineers on downstream development activities
• Design and qualify scale-down models, support process scale-up, and author technology transfer packages for internal and external manufacturing partners
• Conduct process characterization, design of experiments, and risk assessments to establish design space and control strategies
• Contribute to CMC strategies and author regulatory documentation for IND submissions and other filings

Requirements

• M.S. with 10+ years or Ph.D. with 7+ years hands-on downstream process development experience
• Extensive experience in lentiviral vector or viral vector downstream purification and clarification, chromatography, ultrafiltration, and sterile filtration
• Deep knowledge of viral vector impurity profiles and mitigation strategies for host cell proteins and DNA
• Proven experience supporting clinical and commercial scale processes, including technology transfer
• Strong command of cGMP principles, Quality Systems, FDA/EMA guidance for gene and cell therapies, and CMC regulatory submissions
• Advanced expertise in statistical analysis, design of experiments, QbD, and risk management methodologies
• Demonstrated leadership ability in matrixed environments with excellent written and verbal communication skills

Compensation: $142,377.60 - $213,566.40 base annual