GREYRIGGE ASSOCIATES LIMITED - Key Persons
Cora has more than 30 years' experience in pharma, researching and developing biopharmaceuticals, with specific expertise in downstream process (purification) development and in managing and leading technical project teams.
After graduating from the University of Warwick, Cora worked at GlaxoSmithKline in R&D before moving into process development and later into technical project management. Cora has been working as a biopharmaceutical development consultant since 2009. Cora understands the perspective of scientists in both research and development so is well placed to manage the transition of projects from one to the other. Working for GlaxoSmithKline and legacy organisations Cora has coordinated and monitored the activities leading from bench to clinic for 7 products including monoclonal antibody therapeutics and vaccines. She is very familiar with product development activities & their dependencies, so is keenly aware of the many pitfalls that can occur. She therefore knows the importance of risk control including contingency planning. Cora has a proven track record in partnered joint product development teams and in working effectively with external service providers.
Cora's key expertise within CMC is process development and scale-up of biopharmaceutical products. She is also very experienced in the GMP manufacturing of biologicals together with the selection and management of contract manufacturing organisations.
Andrew has been a consultant since 2005 and has worked on many commercial products including the Antibody Drug Conjugates Adcetris and Trodelvy. He started his industrial career at British Biotechnology as a PhD student before joining the Analytical Development Group in AstraZeneca in Macclesfield. Around the millennium Andrew moved to California to work with PowderJect before moving on to Seattle Genetics, where he set up the QC group. Upon returning to the UK, Seattle Genetics became Andrew's first clients as a consultant where he supported their DP processes throughout Europe and has since worked with many organisations around the globe in Quality or Analytical Roles. Andrew also worked with bioprocessUK and the Knowledge Transfer Networks to establish Analytical Development and Formulation Working Groups and communities in the UK.
Job Titles:
- Associate
- Director
- Principal Consultant
- Principal Consultant and Director of GRA
- Principal Consultant and Director of GRA, Has a Passion for Biotech & Data Driven Results but above All, Helping People and Companies Achieve Their Objectives and Grow
Lee is a Director and Principal consultant with experience spanning biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.
Dr. Lee Smith, a principal consultant and director of GRA, has a passion for biotech & data driven results but above all, helping people and companies achieve their objectives and grow. He has been working in the biotech area for over 20 years and has worked with large multinational organisations, small & medium sized enterprises (SMEs) as well as with virtual start-up biotech companies.
Job Titles:
- Associate
- Freelance Consultant
Paul, a freelance consultant with over 25 years of experience. He provides expert statistical training, consultancy and software to scientists. He continues to support R&D, biopharmaceutical process, assay and manufacturing development globally. Paul is an expert practitioner of QbD and Six Sigma, advising organisations on its application as well as appropriate application of DoE tools for the efficient development of their processes, formulation work and assay development. Paul was formerly Principal Statistician and Project Manager with SmithKline Beecham in the United Kingdom. Paul has been working closely with GRA since its inception in 2010.
Richard has more than 20 years experience in the Biopharma industry. Before gaining a Microbiology degree and PhD at the University of Surrey, Richard spent four years as a technician manufacturing marketed veterinary viral vaccines. After graduating Richard spent four years as the GMP production manager at Novartis Animal Vaccines Limited. Richard then joined Microscience/Emergent Biosolutions as a senior manager leading the process development and technical transfer for GMP manufacture of its clinical human vaccine pipeline. Richard has taken research level clinical vaccine candidates and developed upstream and downstream processes suitable for transfer into GMP production. Richard has hands on experience of culturing bacteria and viruses from the laboratory bench to industrial GMP scale. Richard has worked closely with GMP contract manufacturing companies to produce clinical GMP materials with appropriate level of compliance to satisfy regulatory requirements for human clinical trials. Richard has been a Freelance Biopharmacuetical development expert since 2013 helping biopharma companies troubleshoot process and manufacturing issues.
Rod O'Keeffe is a biopharmaceutical consultant with over 25 years of experience in the development of biological products. Rod worked in a senior capacity at Ipsen Biopharma for almost 20 years managing development activities for biological products including clinical supply, characterisation, process development and technology transfer of manufacturing processes into GMP facilities. In addition he worked at Ipsen in Formulation Development as a Manager for biological products developing formulations for LCM and novel proteins. Rod worked in a small biotech company, Cantab Pharmaceuticals, as a Downstream Process Development scientist optimising, scaling up and technology transferring manufacturing processes for a recombinant virus vaccine. He gained his degree in Biochemistry from Liverpool University and obtained his PhD in the manufacturing processes of live viral vaccine products from Aston University.
Dr Ronan O'Kennedy has over twenty years of experience in the biopharmaceutical sector having worked in academia and for large biopharmaceutical companies and CMOs. In 2015, he started consulting on technical services to the biotech industry to speed process development to manufacture and maximise the value of development data. Ronan started his career at the Department of Biochemical Engineering in UCL as a Post Doc researcher focused on Plasmid DNA vaccines. He joined the GSK Bioprocess Development Group in Beckenham in 2000 focused on upstream development of mammalian cell culture & microbial processes for clinical manufacture, In addition Ronan focused on process monitoring & control and technical transfer of processes into clinical manufacturing of mAbs and DNA vaccines. In 2009, he joined the Department of Chemical Engineering at Newcastle University providing a biopharmaceutical industry focus to the Biopharmaceutical Bioprocessing Technology Centre. In 2011, Ronan moved to Fujifilm Diosynth Biotechologies (FDB) R&D where he was Head of Mammalian Cell Culture Process Development. His group focused on development of mammalian cell culture based bioprocesses for manufacture of mAbs and biotherapeutic drugs. Research interests include linking upstream process performance to downstream product quality. He has over twenty five publications and patents in the bioprocessing field. He is particularly interested in data driven process modelling, Process Analytical Tools (PAT) and Quality by Design (QbD) used to maximise the value of process data and its re-use throughout the product development lifecycle.
Ian has over 40 years experience in Quality Assurance. Has worked for Wellcome, GlaxoSmithKline, UCB, Emergent BioSolutions, Eli Lilly, Novartis and MeiraGTx. Ian has fulfilled the role of QP for investigational products and is an experienced auditor with particular expertise in aseptic manufacture. He has predominantly worked on supporting Biopharmaceuticals and more recently Advanced Therapy Medicinal Products (ATMP). Ian is also experienced in the design, build, validation and licensure of manufacturing facilities and the development and implementation of Quality Management.
Samantha is a Director and Principal consultant of GRA with experience spanning over 20 years' working for Biopharmaceutical Companies including GlaxoSmithKline, Ipsen Biopharma, Lonza and Emergent Biosolutions. Sam specialises in all aspects of Method Development and Validation, developing strategies, as well as advising or directly managing assay development and validation programmes for complex biological vaccines, therapeutics and biosimilars. In addition to this, Sam can provide is able to design and manage complex product stability studies and shelf life determinations. Sam has contributed to a number of CMC sections in regulatory agency submissions & scientific advice packs for biopharmaceutical products in Europe, USA and China.