Mark Godfrey Email and Phone Number

Digital transformation and change management: Leading Tech and Scientific teams to implement a modern formulation management system to enable IDMP (Identification of Medicinal Products) compliance ,realise FAIR and digitised drug product data to enable digital AI/ML tools for data insights

Lead cross functional Analytical teams in CMC space through project milestones, from First Time In Human to commercialisation, including responsibility for Analytical sections in global regulatory submissions (IMPD, IND, CTA, MAA, NDA) for small moleculesEFPIA NIR/Multivariate Analysis expert working group Member: Cross pharma consortium currently reviewing revisions of ICHQ2 ICH Q14GSK Associate Fellow - Awarded to top 5% of scientists at GSK

Formed and led high performing multi functional team to deliver international regulatory approval of the Near Infrared method for determining identity and content in a complex bilayer 2 active tablet formulation. Included proof of concept, calibration design, developing and validation predictive chemometric models, determining validation criteria and specification requirements.Providing leadership and strategic direction to cross functional teams to drive the progression of analytical projects through clinical development to regulatory approval.Recognised expert in devising, developing and delivering innovative technologies to modernise, simplify and drive analytical performance.

Provided leadership to analytical teams to support analytical and formulation development on key clinical assets in pharmaceutical development.Expert in method development, validation requirements and specification setting for HPLC, Dissolution, KF, and chemometric predictive modelling of NIR and Raman methods. Ensured delivery of robust phase appropriate GMP compliant analytical methodologies using Quality by Design to meet project milestonesManaged interface between GSK and CRO's Authored analytical section of regulatory submissions and responses to regulatory questions.

Developed and validated robust analytical methods (HPLC/Dissolution/KF) to support pharmaceutical development of oral solid dosage units including In vitro/in vivo and discriminatory dissolution method development

Provided analytical support and data generation to support programs from candidate selection though to commercial release.

Generated analytical data to support process improvements for new products introduced to the factory

EFPIA Multivariate Analysis Expert working group, a cross pharma consortium tasked with review of updates to industry guidelines for Analytical Validation (ICH Q2) and Analytical Procedure Development (ICH Q14) - which were released in Nov 2023