Ashley Vey
Senior Scientist Ii @MeiraGTx
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WORK HISTORY
Senior Scientist Ii @MeiraGTx
London, GB
Process Development, MSATSummary of key achievements and skills from all PD roles at MeiraGTx:Per ‘Product Lead (MSAT)’ role for a late-stage AAV product:• Lead the planning, risk assessment, coordination and review of CMC studies for commercial licensing applications to regulatory guidelines, including: o Process Development for platform integration o Material Generation for Stability, Forced Degradation, Device Compatibility, Method Validation, Bridging, Comparability o Process Control strategy establishment, FMEA• Authored and reviewed sections of Module 3 for BLA & MAA dossiers, and regulatory briefing books, including descriptions of manufacturing process, process development, process and analytical control strategy, Process Validation (PPQ)• Cross-functional engagement toward project successPer ‘Upstream Product Lead’ role for other late-stage AAV product:• Lead the design, planning and execution of pre-PPQ process robustness for upstream process• Lead the successful scale-up and implementation of 200L process in new bioreactor system, including: o PoC runs in different 50L bioreactor systems o Stakeholder engagement on new facility design and tech transfer considerations o SDM qualification for different manufacturing scales o Commercial supply projections and risk evaluation o Engineering runs matching QTPP• Authored sections of CDRP (FDA) briefing document for commercialisation pathwayOther roles, achievements and skills:• Line management of 2 FTE scientists and training staff• Agile Project Management Qualification (DSDM, Foundation & Practitioner)• Self-taught VBA code; developed and implemented macros to reduce data entry tasks from hours to 5x titer increase, lower COGs, higher quality CQAs, improved manufacturing operations.
EDUCATION
Lancaster University
Bachelor's Degree, Biological Sciences
Macquarie University
Bachelor's Degree, Biological and Biomedical Sciences
Richard Taunton Sixth Form College
High School, A Levels in Biology, Chemistry, Music and Music Technology
Upper Shirley High School
High School, 14 GCSEs
SKILLS
ABOUT ASHLEY VEY
An experienced professional in pharmaceutical development, seeking leadership roles within regulatory CMC functions. With >10 years’ experience in biologics (8 years in AAV gene therapy), I bring expertise in bioprocess engineering, process development across the drug product life-cycle and experience in GMP operations. As a detail-oriented, inquisitive and emotionally intelligent person I work well cross-functionally to steer perspective to the big picture (e.g. continued business justification, timeline bottlenecks, budget constraints, understanding priorities/pressures on different groups).Open to roles that are client- or stakeholder-facing, cross-functional project roles that require strong interpersonal skills.
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