Ian Pardo, BSC (HONS), MSC, EU QUALIFIED PERSON

PRACTICE EXPERT

Practice expert with 15 years of experience in IMP and commercial manufacture, quality, validation, clinical trials, regulatory submissions, and remediation activities.

ABOUT IAN

Ian is a Quality Leader in the biopharmaceutical industry, with broad knowledge of biological product manufacture including cell and gene therapies. Ian is an active EU Pharmaceutical Qualified Person.

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.

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.

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 continues to act as an EU Qualified Person, certifying batches of commercial and investigational products for the EU and export.

EXAMPLES OF RECENT WORK

  • Quality and technical audit of GMP manufacturer of cell and gene therapy key process material
  • Due diligence package preparation in support of pre-merger activities
  • Assessment of design and qualification documents for a new multi-product facility including HVAC, steam and process gases

PAST EXPERIENCE

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

EDUCATION

NSF Heath Sciences
Eligible EU Pharmaceutical Qualified Person

Universities of Manchester, Salford and Keele
M.Sc. in Molecular Parasitology and Vector Biology

University of Sussex
B.Sc. (Hons) Molecular Genetics in Biotechnology

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