BioOutsource — cGMP compliant biotesting
People
Dr Daniel Galbraith – Head of Operations
Daniel joins BioOutsource from his previous very successful position as Head of BioSafety at Covance Laboratories Europe. For the past 12 years Daniel has worked in the Biotechnology field either in contract research or manufacturing. After being awarded his PhD in immunological and molecular biology studies in 1992, Daniel held two post-doctoral positions in virus research within a clinical setting before joining Q-One Biotech. His final position, after successfully leading a number of different teams within Q-One Biotech was as Director of Regulatory Affairs. After leaving Q-One Biotech Daniel joined MedImmune UK in the Virus Vaccine Division, Quality Control leading the Virology department. Daniel has a keen interest in virus vaccines and their testing to meet regulatory guidelines. Daniel has overall responsibility for running the operations laboratory, regulatory affairs and business development.
Gillian Hill – Head of Quality
Gillian joined as a founder member of BioOutsource and comes with over 20 years experience of cGMP and GLP, having held various managerial and senior leadership Quality and Lean Six Sigma (LSS) roles within in Q-One Biotech, Invitrogen and BioReliance. In her Qualified Person (QP) capacity, Gillian was responsible for release of aseptically produced IMPs. Gillian has successfully prepared for and led several GLP and cGMP inspections by the MHRA (including initial inspection for a Manufacturers Authorisation (MA) required for clinical manufacture), in addition to an FDA inspection. In her Functional Excellence role within BioReliance, Gillian, who is Six Sigma Green Belt (GB) qualified and Black Belt (BB) trained, had direct leadership responsibility for driving significant strategic, quality and client-focused improvements throughout the company. Gillian has an Honours BSc from Glasgow Caledonian University, and has overall responsibility for the Quality Systems, Systems Improvement and Information Technology.
Dr Carron Nairn – Head of Molecular Services
Carron joined as a founder member of BioOutsource and comes with a wealth of experience of Molecular Biology from Invitrogen, BioReliance and Q-One Biotech. After gaining her first degree from Glasgow Caledonian University, Carron completed an M.Sc. in the field of Ovarian cancer research and subsequently completed a PhD studying enteroviruses and their relationship to chronic diseases. After a three year postdoctoral position studying Hepatitis C virus replication with Glasgow University, Carron completed her academic training and joined Q-One Biotech as a Molecular Biologist, eventually leading a team of scientists within the group. Carron has overall responsibility for the molecular studies including development, qualification and validation of assays. Her experience of a number of different molecular biology techniques has given her an expert knowledge on the analysis of products using amplification technologies.
Andy Upsall – Head of in vitro Services
Andy joined as a founder member of BioOutsource and having previously gained experience in Bioassays from Covance Laboratories and MedImmune (UK). Andy leads the in vitro Services group working on biological potency and virus detection. After graduating from Manchester with his first degree in Biochemistry, Andy followed this with further training to gain an M.Sc. in Neuroscience before joining MedImmune (UK) and becoming involved in the batch release of the first licensed Live Influenza virus vaccine. Andy joined Covance Laboratories in 2005 where he became a lead scientist in the BioPotency group. Andy has overall responsibility for the in vitro cell based studies including development, qualification and validation of assays. His experience of a number of different molecules has given him an expert knowledge on the analysis of Biological potency assays for batch release and the detection of Anti-drug Antibodies.