Andy is a PRINCE2 practitioner qualified project manager with over 15 year experience of successfully leading and delivering projects in both the Large Molecule Biotechnology and Medical Device industries. Working with the industry’s leading multinational corporations he has a proven track record of using traditional project management tools and techniques to deliver on time and on budget innovative solutions to defined client deliverables.
He holds an Honours degree in Applied Biology from Northumbria University and has extensive experience managing projects within ISO and cGMP regulated environments within the U.K, EMEA, and Worldwide
Andy has a strong client focus and excellent communication skills, he excels at developing and building client relationships into trusted partners by ensuring on time and on budget project delivery through effective and open client communication, project visibility and control of all aspects of the project critical pathway accomplished utilising risk and stage gate management processes.
With a strong passion for continuous improvement using industry recognised Kaizen, Gemba and Root Cause Countermeasure techniques which he leverages to solve problems and drive process improvements throughout all levels of the organisation.
Angela is a microbiologist and has worked in drug development in the pharmaceutical industry for over 30 years, both in big pharma and CRO environments. She has experience in non-sterile and sterile products and her role includes providing advice to clients with respect to pharmaceutical microbiology and microbial quality assurance.
Angela graduated from the University of Strathclyde with an Honours degree in Applied Microbiology and over her career has been a member of various working groups within the industry including for bacterial endotoxins
A chemistry research scientist by background, Giovanni is a committed CMC Regulatory Affairs Specialist and Project Manager, with large experience in the pharmaceutical industry, principally in the development of new chemical entities for use in pre-clinical and clinical studies.
After receiving his Diploma of Research in Biochemistry from the University of Bourgogne, France, he attained his Laurea (Master of Science Degree) in Organic Chemistry at the University of Bologna, Italy.
As a member of TOPRA, he has acquired a broad knowledge of regulatory affairs in the pharmaceutical industry, and specialises in writing CMC dossier sections for regulatory submissions.
He is an APM qualified Project Manager, with expertise in managing pharmaceutical projects for multinational clients, going from chemistry research and synthesis of drug substance, to development of drug products for early phase clinical trials.
Alex has over 6 years experience in working pharmaceutical and contract research environments including both small and large scale development and production of pharmaceutical products
He holds a Master’s Degree with honours from the University of Hull in Chemistry and Molecular Medicine and is also a committed member of the Royal Society of Chemistry. An experienced project manager, Alex works with multiple clients requiring varying levels of guidance and expertise and has a track record of end to end project management and is a specialist in regulatory dossier filings for clients in Europe and America.
“I take pride in working for a CRO company with such a high priority in customer communication focusing on supporting all the requirements from the customer every step of the way. This enables us to work together, closely and effectively, to meet and exceed your goals.”
Mark is an organic chemist with over 10 years’ experience working in the pharmaceutical and fine chemical industries. He has particular expertise in Process Development and managing the scale-up of technically complex processes from grams to kilograms.
After graduating in Chemistry from the University of Manchester, Mark completed post-graduate studies in total synthesis at the University of Leeds He has extensive experience of working in a cGMP regulated environment and has a particular focus on controlling potential chemical reaction hazards and the management of Process Safety.
“Taking a lab procedure and developing it into one that can produce kilos of high value product safely, efficiently and with consistently high quality, is a challenge that is always enjoyable to address”
Richard has seven years’ experience working in the pharmaceutical industry in both the contract research and contract manufacturing sectors, including over three years’ experience of leading teams in the development of small molecule syntheses to deliver gram to kilogram quantities of API and pharmaceutical intermediates.
He holds a PhD from the University of Nottingham for research undertaken in natural product synthesis and is a member of both the Royal Society of Chemistry and the Society of Chemical Industry.
Richard has a proven track record of new product introduction, from quotation through to product delivery and has led projects incorporating GMP manufacture and coordination of multifunctional project teams.
“Working with experts in their field to develop high quality, safe and efficient routes to complex APIs for drug development, clinical trials and ultimately commercial supply is a hugely rewarding experience.”
After arriving at the Alnwick site as a formulation scientist, Simon now has over 30 years experience within pharmaceutical R&D formulation development, technical transfer and clinical manufacturing, spanning both “big pharma” and CRO environments. His responsibilities include providing advice to clients with respect to their manufacturing needs.
After graduating in pharmacy from the University of London, Simon completed a PhD in pharmaceutical microbiology from the University of Nottingham.
Simon is a registered pharmacist and is named on ARCINOVA's IMP Manufacturing Authorisation as the Head of Production, responsible for the manufacture and supply of IMPs to the clinic.
“Working in a CRO environment provides the opportunity to work with many people on multiple, fast turnaround projects. The variety and achievement in delivering quality products provides a great intrinsic reward.”
John leads the Quality Assurance activities at ARCINOVA, spanning GCP, GLP and GMP; he has been a member of RQA for over 20 years. John has over 30 years experience in the pharmaceutical industry with global pharmaceutical and contract research organisations, initially in lab-based roles before moving into Quality Assurance.
John is a Life Sciences graduate from Napier University in 1991, with a Certificate in Quality Management from Newcastle College (1995) and a Diploma in Research Quality Assurance from Anglia University (1997).
“Quality is at the heart of everything we do.”
David is an analytical chemist and has worked in drug development in the pharmaceutical industry for over 30 years, both in big pharma and CRO environments. He has extensive experience in Quality Control, stability, method development and validation.
David has an Honours degree in Applied Chemistry and his role includes providing advice to clients with respect to all aspect of pharmaceutical analysis and Quality Control of drug substance and drug products.
“To assure the quality of drug substances and products, you need a team who have great knowledge of both analytical chemistry and the GMP regulations, and you can trust to deliver high quality data.”
Lee is a biologist with 25 years experience of drug development in the pharmaceutical industry. Key roles and responsibilities have included managing a team conducting drug metabolism, exploratory bioanalysis and in vitro biochemical assays. Lee is an experienced Study Director and lead scientist, responsible for the development of new technologies (eg LC-MS metabonomics platform).
Lee is a graduate in Applied Biology from the University of Hertfordshire,
"The great days at work are when we find a way to overcome a client’s challenge and this new insight gives their data meaning and understanding. That’s why it’s easy to become invested in a client project."
Alan is a PhD Organic Chemist with over 20 years experience in the synthesis of radiolabelled and stable labelled compounds. He has worked for a number of major organisations, including Sanofi, Covance and Wellcome. Alan completed his PhD at the University of Manchester and subsequently undertook Post Doctoral work at the University of Nottingham with Prof. G. Pattenden. He has extensive experience of working in a GLP/GMP regulated environment and acts as Site Radiation Protection Supervisor (RPS) with experience in dealing with regulatory bodies such as the Environment Agency (EA).