Mission
AssociateDirector,ViralVectorProcessDevelopment,Upstream
“Associate Director, Viral Vector Process Development, Upstream at Mission. Skills: Upstream Process Development, Lentiviral Vector Manufacturing, Suspension Bioreactor Platforms. Lead upstream processes. Drive innovations”
What You'll Achieve.
Improve titer; Improve quality; Improve robustness; Improve cost; Establish design space; Late-stage readiness
Industry & Context.
Troubleshooting; Problem-solving; Root cause analysis
What They're Looking For.
Must Have
Advanced degree (PhD) or MS, 6+ years relevant experience, 10+ years relevant experience, Deep expertise LVV process development, Scale translation to clinical/commercial, Process characterization, Technology transfer, Advance programs research through IND, Mastery upstream unit operations, Application statistical DOE, Application data analytics, Practical experience cGMP manufacturing, Phase appropriate validation, Contribute to regulatory filings, Ability to lead teams, Influence in matrix environment, Communicate complex technical concepts, Troubleshooting and problem-solving skills, Experience single-use bioreactors, Experience process automation, Experience PAT, Experience digital lab systems
Nice to Have
Success scaling suspension-based LVV, Familiarity upstream-analytical linkages, Experience defining process controls, Experience preparing process/manufacturing sections, Participate in health authority interactions, Track record implementing Lean practices, Robust documentation knowledge management
What You'll Do.
Lead upstream processes
Design scale-up strategies
Establish scale-down models
Lead phase-appropriate validation
Lead technology transfer
Oversee experimental design
Establish design space
Implement knowledge management system
Maintain knowledge management system
Provide technical guidance
Promote culture of safety
Promote scientific rigor
Promote continuous improvement
Ensure generation documentation
Implement fit-for-purpose systems
Implement business processes
Perform process performance trending
Perform root cause analysis
Perform corrective/preventive actions
Collaborate with internal partners
Collaborate with external suppliers
Support sourcing bioreactors
Support qualification bioreactors
Support sourcing mixing systems
Support qualification mixing systems
Support sourcing raw materials
Support qualification raw materials
How You'll Work.
Team & Collaboration
Matrixed environment; Internal partners; External suppliers; CDMOs
Communication Scope
Communicate complex technical concepts
Process & Methodology
IND enabling, Late-stage readiness
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