Alexander Edwards Email & Phone Number

North West, Uk

Technical and scientific consultant working within biotechnology and IVD industries. Expertise in:-Technical and regulatory aspects of IVD and medical device design and development processes-IVDR-IVD verification and validation-Working within regulated environments with quality systems for example ISO, GLP and GMP-Molecular biology and cell biology techniques e.g. PCR, cell culture, assay development-Project management-Team management-Process improvements-GLP Study Directing-Use of OECD test guidelines for cosmetic and chemical testing e.g. skin sensitisation

United Kingdom

Currently working on assessment of scientific/technical aspects of in vitro diagnostic device technical files to meet IVDR for rapid diagnostic products.

Daresbury, Cheshire

Responsible for planning, delivery and reporting of regulatory (GLP) and non-regulatory studies for clients. Manage development and implementation of new in vitro and in chemico methods and associated regulatory documentation. Contribute to the industry on a global level by participation in the OECD expert working group for skin sensitisation including test guideline review and submission of scientific content. Oversight, support and line management of scientific team including lab scientists and study directors. Scientific leadership and liaison with clients with regards to technical aspects of studies. Communication both within XCellR8 and when working with clients. Drive process improvements, design and implement new tools/systems for improving efficiency and ways of working.Specific experience with skin and eye irritation studies, skin sensitisation test methods, genotoxicity screening, cytotoxicity and other in vitro methods. General methods including HPLC, Flow Cytometry, cell culture studies, cell health assays and screening.

Manchester, United Kingdom

Product Development Lead, MDx Assay Technologies.ExperienceProduct development lead for infectious diseases assays for fully integrated QIAsymphony & RGQ platformsResponsibility for timely delivery of product development/technical aspects of projects against stringent quality and regulatory standardsExpertise in DOE, management of development lifecycle of products, assay verification and implementation of assays on automated integrated systemsResponsibility for leading product development teams towards delivery of project related goalsEffective communication with project stakeholders and external collaboratorsCollaboration with quality assurance department for CAPA investigationsContribution to other projects such as specialised sample preparation for swab based assays on the QIAsymphony, external partnership on respiratory panel assay and LCM activities

Salisbury, United Kingdom

Project manager for respiratory viral panel assay. Development of highly multiplexed PCR assays for the in vitro diagnostics market. Experience with multiple PCR platforms and signalling technologies, nucleic acid extractions, integration of assays onto novel diagnostic platforms, analysis of amplified products using capillary electrophoresis.

Immunology, cell and molecular biology of inflammatory bowel disease. Investigated role of epigenetic modifying compounds upon inflammatory cytokines and pathways in Crohn's disease and Ulcerative Colitis.

Palo Alto, California

HIV assay research and development for assessment of novel therapeutic compounds.

Phd, Respiratory Research

Investigation of the interaction between structural and inflammatory cells of the lung to produce changes in matrix metalloproteinases.

M. Pharmacol (Hons), Pharmacology, 2:1