AstraZeneca
Healthcare
AssociatePrincipalScientist,ViralVectorDownstreamProcessDevelopment
“Associate Principal Scientist, Viral Vector Downstream Process Development at AstraZeneca. Skills: Viral vector downstream, Process development, Purification, Technology transfer. Define downstream purification strategies. Develop downstream purification strategies”
What You'll Achieve.
Expand Cell Therapy portfolio; Expand Gene Therapy portfolio; Establish robust processes; Establish scalable processes; Establish phase-appropriate processes; Support clinical readiness; Support commercial readiness; Support IND-enabling studies; Support clinical manufacturing; Support commercial manufacturing; Support process characterization; Support comparability studies; Support scale-up to pilot; Support scale-up to clinical; Support scale-up to commercial; Support regulatory filings; Define design space; Define control strategy; Improve efficiency; Improve robustness
Industry & Context.
Root cause investigations; Troubleshooting
What They're Looking For.
Must Have
M.S. with 10+ years industry experience, Ph.D. with 7+ years industry experience, Extensive hands-on LVV downstream process development, Deep expertise in clarification, Deep expertise in chromatography, Deep expertise in UF/DF (TFF), Deep expertise in sterile filtration, Working knowledge of cGMP principles, Working knowledge of Quality Systems, Working knowledge of FDA guidance, Experience contributing to CMC sections, Advanced experience with statistical analysis, Advanced experience with DOE, Advanced experience with multivariate data interpretation, Application of QbD principles, Application of risk management, Application of process justification methodologies, Excellent written communication skills, Excellent verbal communication skills, Ability to lead in matrixed environments, Ability to influence stakeholders, Ability to resolve complex technical challenges
Nice to Have
LVV downstream process development experience, Other viral vectors biologics experience, Track record of scaling LVV purification, Track record of scaling viral vector purification, Experience supporting technology transfer to GMP, Experience supporting technology transfer to CDMOs, Exposure to PAT, Exposure to digital tools, Exposure to data management systems, Exposure to knowledge management systems, Success in building next-generation purification processes, Success in delivering next-generation purification processes
What You'll Do.
Define downstream purification strategies
Develop downstream purification strategies
Execute downstream purification strategies
Establish purification processes
Provide scientific leadership
Provide technical oversight
Lead matrixed project teams
Influence cross-functional teams
Drive alignment on technical strategy
Drive alignment on timelines
Drive alignment on decision-making
Ensure high-quality experimental design
Ensure high-quality execution
Ensure high-quality data interpretation
Ensure timely communication of results
Design scale-down models
Qualify scale-down models
Author technology transfer packages
Review technology transfer packages
Approve technology transfer packages
Support implementation at GMP sites
Support implementation at CDMOs
Contribute to CMC strategies
Lead process characterization
Lead platform studies
Apply risk assessments
Apply scientific justification
Drive root cause investigations
Drive troubleshooting
Drive continuous improvement initiatives
Identify novel purification technologies
Evaluate novel purification technologies
Identify next-generation purification technologies
Evaluate next-generation purification technologies
Champion platform evolution
Champion efficiency gains
Champion robustness improvements
Ensure development activities adhere to cGMP
Ensure data integrity
Ensure Quality Systems expectations
Author development summaries
Review development summaries
Author technical documents
Review technical documents
Interface closely with Quality
Ensure inspection readiness
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Matrixed project teams; External CDMOs; Quality; Manufacturing; Regulatory
Communication Scope
Written communication; Verbal communication; Technical documentation; Regulatory submissions
Process & Methodology
Project teams, Timelines, Decision-making
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