Mitchell Rosner Email Address

Vice President of Quality

AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology.

My 30+ years of postdoctoral experiences of strong cross-matrix management and budgeting skills plus diverse technical background have been a strong addition to many teams. My start up experiences required virtual business approaches while my larger company experiences stressed building and maintaining infrastructure; these fit a variety of business models. My skills as as project leader and formal training in project and program management have helped enhance efficient cross matrix teams and departments meet specific goals on time and budget. My biologics, small molecule, food, nutritional supplements, drug and device experiences have given me a broad picture of the cGMP and GLP needs to drive product development through the clinic. I have been a contributor on 6 approved products and an inventor on one approved product. My quality and regulatory responsibilities in several companies have been demonstrated by authoring submissions to Health Authorities in multiple countries, building quality systems, and leading the laboratory Pre-Approval Inspections and as a Board Member of IPAC-RS for 2 years. Applying my strong quality, analytical and metabolomic skills to biofuels applications has been integral in solving problems and creating solutions in an evolving cutting edge organization. Specialties: CMC: 1) Analytical Methods Development + Validation 2) Quality Control for all phases of development + commercial 3) Stability for drug substance and product + devices 4) Pre-formulation + formulation 5) PAI readiness Quality (21 CFR 11, 110, 111, 210-211 600-680, 820): 1) All relevant Documents and SOP's for Quality Systems, Quality Agreements, HACCP 2) Analytical/QC Labs GLP and cGMP 2) Specification setting and shelf-life 3) Investigations of OOS, OOT + OOE 4) Audit of cGMP + GLP CRO's 5) Hosting GMP audits by Third Party and Regulatory Bodies Preclinical: 1) Test article manufacture and characterization + stability 2) Toxicology studies + audits 3) Metabolomics