Eligible QP. Experience in IMP and commercial manufacture, quality, validation, clinical trials, regulatory submissions, and remediation activities
Facilities, Manufacturing, & Compliance
Quality Assurance
Regulatory Affairs
Diligence & Business Strategy
Ian is a Quality Leader in the biopharmaceutical industry, with broad knowledge of biological product manufacturing including CGT.
Ian joined Dark Horse Consulting as a Practice Expert in 2019, bringing with him over 15 years of experience of IMP and commercial manufacture, quality, validation, clinical trials, regulatory submissions, and remediation activities. During his career, he has been a part of companies ranging in size from small innovation start-ups to large global pharmaceutical organisations.
For Dark Horse clients, Ian has led the remediation of manufacturing sites under regulatory action, including focused audits, leading technical workstreams, process mapping, QMS remediation, and managing communications with the appropriate agencies. Ian has acted as an EU Qualified Person, certifying batches of commercial and investigational products for the EU and export.
Before joining Dark Horse, Ian most recently served as Director of his own consultancy, providing Quality and EU QP services to the Pharmaceutical industry to small and large Pharma for commercial and investigational products. Ian has worked with organisations to launch biological products in the USA and EU (as an EU QP, he supported clinical trial supply globally), and helped organisations struggling with systems and processes that have not kept pace with their organisational growth.
Earlier in his career, Ian’s focus was on IMP manufacture, working with microbial and mammalian cell lines in stainless steel and disposable systems manufacturing plasmids, viral vaccines and viral vectors. Ian took an interest in validation, and became responsible for the qualification of new equipment, including bioreactor systems, and autoclaves. Ian led an upstream project to a switch from traditional stainless steel process chain to a fully disposable system for an adenovector Phase II/III product.
Spires Quality Limited
Director, Quality Consultant & EU Qualified Person
Oxford Biomedica
QP and Senior Quality Specialist
Pfizer
EU Qualified Person and Quality Manager – Anti-infectives and Oncology
Senior Quality Manager – Contract Quality Operations
Hospira
EU Biologics Quality Manager
Circassia
Quality Manager – GMP/GCP Allergy
Health Protection Agency
Quality Systems and Validation Manager
Cobra Biologics
Production Supervisor
NSF Heath Sciences
Eligible EU Pharmaceutical Qualified Person
Universities of Manchester, Salford and Keele
MSc. in Molecular Parasitology and Vector Biology
University of Sussex
BSc. (Hons) Molecular Genetics in Biotechnology
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