Expert in Medical Devices and Biopharmaceuticals Design, Development, Manufacturing, and Business Development
Expert ID: 728004 United Kingdom
|Year: 2020||Degree: LLB||Subject: Law||Institution: The Open University|
|Year: 1978||Degree: PhD||Subject: Biochemistry||Institution: Dundee University|
|Year: 1968||Degree: BSc||Subject: Zoology/Physiology||Institution: London University|
|Years: 2002 to Present||Employer: Undisclosed||Title: Consultant||Department:||Responsibilities: He undertakes a variety of limited-term and part-time contracts - project management, process development, product and service development, technical and market evaluations, IPR/patent evaluation, market research, training, quality systems development, quality audit, environmental audit & management, option appraisals, feasibility studies, business planning, business development, funding applications.|
|Years: to Present||Employer: Undisclosed||Title: Senior Manager||Department:||Responsibilities: He undertook various roles including R&D, quality & regulatory affairs and business development with regard to:
Diagnostic medical device development, manufacture and marketing, and
Contract services to the diagnostic, biotechnology and pharmaceutical industries.
|Years: to Present||Employer: Undisclosed||Title: Research & Development Manager||Department:||Responsibilities: He was responsible for the development and manufacture of biopharmaceuticals (blood products) and in vitro diagnostics.|
|Years: to Present||Employer: Undisclosed||Title: Head of Development||Department:||Responsibilities: His responsibilities involved the development and manufacture of human and veterinary diagnostics.|
|Years: to Present||Employer: Undisclosed||Title: Director of Research & Development||Department:||Responsibilities: His responsibilities in this biotechnology company included:
Basic medical research,
Development of clinical diagnostics,
Provision of laboratory diagnostic services,
Marketing of in vitro diagnostics, and
Contract research & development.
|Years: to Present||Employer: Undisclosed||Title: Lecturer and Clinical Biochemist||Department:||Responsibilities: His responsibilities included:
Provision of clinical diagnostic services (local and national).
Development, manufacture and distribution of diagnostic products.
Medical and biochemical research.
Teaching; undergraduate and postgraduate.
|Years: to Present||Employer: Undisclosed||Title: Research Scientist||Department:||Responsibilities: His reponsibilities included:
Research, development and application of diagnostic tests.
|Associations / Societies|
|CBiol, FSB - Chartered Biologist; Fellow of the Society of Biology.
FIQA - Fellow of the Institute of Quality Assurance.
MCMI - Member of the Chartered Management Institute.
|Licenses / Certifications|
|(CB)MRCSHC - registered cliinical scientist.
BSI Lead Assessor certificate.
|Training / Seminars|
|Lectured in biochemistry and medical sciences.
Lectured in business and management studies.
As a consultant and a volunteer, organised training courses for a variety community-based projects, including museum skills and environmental and climate change issues,
|Sourced and selected suppliers in all his roles. Carried out supplier audits, particularly with regard to compliance with regulatory requirements.|
Fields of Expertise
biopharmaceutical, in vitro diagnostics, quality assurance, quality auditing, quality control, quality management, business management, business development, biomedical device manufacturing, biomedical research and development, contract manufacturing, new product development management, research and development, market segmentation, manufacturing quality assurance, medical device marketing, change management, In Vitro Diagnostics Directive 98/79/EC, market development, business startup, market positioning, marketing mix, market assessment, clinical diagnostics, manufacturing facility design, ISO 9000 auditing, in vitro diagnostics Food and Drug Administration code, ISO 9000 series quality system standard, ISO 9000 quality system documentation, immunodiagnostics, manufacturing process development, manufacturing technology, ISO 9000 implementation, manufacturing process optimization, design for manufacturability, medical device manufacturing, market research, clinical immunology, total quality management, Good Manufacturing Practice, Good Laboratory Practice, diagnostics