James Bourassa

Background

About James Bourassa

Principal Scientist in biotech R&D with extensive senior director level experience in analytical development for drug substance and drug product from discovery to commercial launch. High level of expertise in a wide variety of analytical techniques with unique background in biotech from academic inception of ideas through discovery, all stages of development and successful commercial launch. Sought after for training and mentoring of scientists and supervision of research. Core Competencies: •Writing and review of INDs and NDA •Review and management of ICH registration stability •Collaboration with Chemistry, Pharm Sciences, Quality, Regulatory •Management of method transfer/validation at CROs •In-house analytical methods development and validation •Management of bioanalytical methods development and analysis at CROs •High throughput automated screening for physical properties of drug targets •Analytical support of drug discovery and development •Metabolic stability and metabolite studies •Solid dosage formulation development (IR and CR tablets, drug in capsule) •Oral solutions/suspensions, IV and Transdermal drug delivery •Characterization of nanoparticle suspensions •Setup and maintenance of analytical laboratories Analytical Techniques Include: •Reverse and normal HPLC/UPLC •Liquid and solid HT automation •Autosampling systems •Dissolution and release methods •Mass spectrometry •Gas chromatography •FTIR, Raman, near-IR •Extractables and leachables