Steve Whitelock

Biography

Steve is a highly experienced CMC lead and subject matter expert with a successful career which spans over 35 years in the pharmaceutical industry. He has broad technical and scientific reach, able to support CMC activities from pre-clinical phase through to commercialisation.

Steve was formerly Director of Product Development at Mundipharma Research Limited with managerial responsibilities for the drug product pilot plant and analytical laboratories. He has executed global & European in-house and outsourced drug development projects and product projects across drug delivery platforms ensuring technical success of oral solid dose (immediate and sustained release), transdermal, parenteral, and oral mucosal thin film products.

Steve’s expertise includes analytical method development, validation, inter laboratory method transfer, drug and product characterisation, degradation pathway elucidation, release, and stability testing. He can advise on and support outsourced projects, having built and managed extensive effective networks with contract organisations to develop drug substances and development products. Steve can also advise on CMC regulatory aspects as he is an experienced author, reviewer and approver of quality sections of clinical trials applications, marketing applications and applicant response to regulatory authority questions.

He is a skilled people manager/product technical development lead. Having led cross functional matrix teams and line managed direct reports including recruiting, empowering, motivating, mentoring and developing individuals.

Steve has a proven track record of innovation generating intellectual property encompassing synthetic organic chemistry – compounds of matter, drug delivery platforms – hot melt extrusion technology, abuse deterrent formulations and transdermal drug delivery.