Ian Rosbottom
Principal Scientist - Early to Late Clinical Development @GSK
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WORK HISTORY
Principal Scientist - Early to Late Clinical Development @GSK
Stevenage, GB
I lead the solid-state characterization and physical form strategy for small molecule drug substances and drug products across oral solid dose, inhaled, and long-acting injectable platforms. My work bridges early-phase development and commercial readiness, generating the physicochemical insights needed to design efficacious formulations and support robust clinical and regulatory decisions.Early Phase Development:Established and lead a thermal analysis platform for the rapid, high-throughput assessment of the physical stability of amorphous drug substances and amorphous solid dispersions.Screen and design spray drying processes for the formation of engineered amorphous particles.Drive structural characterization innovation using powder X-ray diffraction (XRPD) and Crystal Structure Prediction (CSP).Accountable for consistent risk assessments of amorphous formulation strategies, communicating clear recommendations to project stakeholders.Mid-to-Late Phase Development (Commercial Readiness):Lead solid form understanding of salts, hydrates, and polymorphs to de-risk commercial development and support IP strategy.Develop, qualify, and validate physical characterization methods including XRPD, Gravimetric Vapor Sorption (GVS), Differential Scanning Calorimetry (DSC), and advanced image analysis.Conduct materials-sparing assessments of critical powder properties—particle size, morphology, flow, and compressibility—to predict and mitigate manufacturing risks.Author and review regulatory filings (IND, NDA, MAA) and provide expert scientific responses to health authority questions on solid-state chemistry.
EDUCATION
University of Liverpool
Master's degree, Chemistry
SKILLS
ABOUT IAN ROSBOTTOM
I am a scientific advisor and project leader specializing in pharmaceutical materials science and CMC strategy. I help teams navigate the critical interface between drug substance properties and drug product performance, ensuring that formulation decisions are backed by robust physical characterization and sound risk assessment.My expertise spans the entire development lifecycle. I lead thermal and structural analysis to assess amorphous stability, direct particle engineering for complex delivery systems (oral, inhaled, injectable), and provide the solid-form governance required for commercial success and regulatory approval. I am accountable for translating complex data into clear recommendations for stakeholders and for authoring high-quality regulatory submissions.
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