Associate Principal Scientist, Viral Vector Downstream Process Development

AstraZeneca · Gaithersburg, MD

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CMCFull-time$142k–$214kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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