Life Science and CMC Analytical Development Consultant with 10+ years of experience advising and leading analytical strategy across monoclonal antibodies and advanced therapies, including AAV9, lentiviral vectors, and retroviral vectors. Proven expertise in assay development, qualification/validation, analytical control strategy, tech transfer, and reference standard lifecycle management within GLP/GMP regulated environments. Strong track record supporting biotech startups, CDMOs, and sponsors through clinical development, CRO/CDMO oversight, and regulatory-aligned documentation.

Consulting & technical epertise

CMC Analytical Strategy & Analytical Control Strategy (ICH Q2(R2), Q6B)
Monoclonal Antibody & Protein Characterization
Gene Therapy Analytics (AAV, LVV, RVV)
Assay Development, Qualification, Validation & Lifecycle Management
SEC-HPLC, CE-SDS (R/NR), cIEF Method Development
ddPCR/qPCR, VCN Titer, Potency & Binding ELISA, Cell-Based Assays
Corporate Reference Standard Generation & Lifecycle Management
Tech Transfer to QC, CRO/CDMO Oversight
Stability Study Design & Data Interpretation
Startup Lab Setup, Talent Mentoring & Team Leadership
Client-Facing Scientific Leadership & Regulatory Support