Mr Mark Proctor, AstraZeneca

Mark Proctor is the Vice President and Site GM for AstraZeneca UK Operations in Macclesfield (UK), where over 1500 colleagues perform a range of manufacturing across oral solid dose formulation, parenterals, sterile manufacturing, and packing for global distribution to over 117 markets worldwide. Prior to this role, Mark has held several senior roles across biopharmaceutical development, quality, supply chain, vaccine technical operations, and site leadership. In addition to his role at AstraZeneca, Mark is a lay-council member and trustee for the University of Liverpool, and a Trustee Director for the AstraZeneca UK Pension Fund. Mark is a Fellow of the Institute of Chemical Engineers, holds a Master’s degree in Biochemical Engineering (UCL), an Executive MBA (Bayes Business School, London), and Certificate in Company Direction (IoD). He was recognised nationally with a CBE in the 2021 Queen’s Birthday Honours in recognition of his services to the Covid-19 response.

Mr Sam Brooks, Information Integrity Innovations Ltd.

Sam Brooks started his professional career as a control systems engineer and moved through various engineering, real-time computing and IT management roles. He now has more than 30 years of experience in the life sciences sector most of which has been managing various aspects of information and systems compliance. Sam now consults on IT governance, risk management and compliance and has recently led major data integrity and quality systems remediation projects.

Mr Joseph Green, Eramol Ltd.

Loughborough University graduate Joseph Green is a Chemical Engineering MEng professional with extensive experience in sterile manufacturing, process engineering, and validation within regulated pharmaceutical environments. Beginning his career as a Process Engineer at Patheon, he went on to specialise in process validation and thermal processing at Campden BRI. Joseph later joined Eramol, a leading sterile fill-finish facility, where he has played an instrumental role in the design and build of a new sterile cleanroom facility. He has led and managed the sterile team through equipment qualification, validation activities, and GMP readiness preparations for MHRA inspection. Following facility commissioning in June/July 2026, Joseph will continue as the business’s Sterile Subject Matter Expert (SME) and team leader, supporting ongoing operational excellence and regulatory compliance.

Dr Ian Houson, Digital CMC Cersi, CMAC

Ian is an experienced pharmaceutical scientist and technology leader with a strong focus on Quality by Digital Design (QbDD) and the practical application of digital tools in pharmaceutical manufacturing. He is currently the programme manager for the Digital CMC CERSI (Centre of Excellence in Regulatory Science and Innovation) led from CMAC, University of Strathclyde to accelerate and realise the full benefit of the adoption of digital tools in regulatory submissions. His work sits at the intersection of process understanding, data analytics, and regulatory-aligned quality frameworks, enabling robust and knowledge-driven scale-up and manufacturing systems. His previous roles in industry were in agrochemicals and pharmaceuticals process development, scale-up and manufacturing at an SME, a CDMO and large pharmaceutical sites in a range of technical, managerial and consultancy positions. He has authored numerous patents, papers and is the Editor of “Process Understanding for Scale-up and Manufacture”. Ian holds a DPhil in organic chemistry with Prof John Brown FRS, University of Oxford and a BSc Hons in Chemistry with Oceanography from the University of Southampton.

Mr Ian Jackson, MHRA

Ian joined the MHRA in 2005 as a GMP inspector. He has since had various roles at MHRA. Areas of responsibility have included GMP inspection planning (UK & Overseas), training of inspectors, inspectorate risk management, and management of the team responsible for Manufacturing & Wholesale Dealer Authorisations and Export Certificates. As well as domestic inspections, Ian has inspected manufacturing sites in India, China, USA, Brazil, Thailand, Dubai and Indonesia. In his current role, Ian is involved in international work with regulatory partners through PIC/S and ICMRA, and with UK-MRA partners including EMA through the Inspectors Working Group. Ian has also audited medicines authorities under EMA JAP and PIC/S JRP programmes including Japan, Malta & Portugal. Prior to joining the Agency Ian worked for several years in industry and is eligible to be named as a QP.

Mr Tishwant Kanwarjit, Autolus

Tishwant Kanwarjit is a Site Quality Executive Director based in London, UK, leading the site Quality function with accountability for compliance, quality systems, and inspection readiness. In this role, Tishwant provides strategic and operational leadership across QA Compliance, Validation, QP, and QA Operations, ensuring robust quality oversight and alignment with regulatory expectations. Tishwant leads and develops a multidisciplinary Quality leadership team, driving a strong quality culture, continuous improvement, and effective partnership with site and global stakeholders to support reliable product supply and business growth.

Mr Bruce Klopfenstein, GSK

Global CQV and Turnover Leader with 30+ years delivering GMP-compliant facilities, equipment, utilities, and computerised systems across pharma, biotech, ATMP, and semiconductors. His experience spans full lifecycle commissioning, qualification, validation, construction turnover, and regulatory readiness for projects ranging from $50M expansions to multi-billion-dollar greenfield sites. Specialising in ISPE C&Q Baseline Guide v2, ASTM E2500, CSV/CSA - 21 CFR 11, and risk-based qualification, with expertise in building teams, simplifying workflows, accelerating startup, and ensuring regulatory compliance. Bruce has led CQV and turnover groups of up to 30 engineers, delivered facilities across Europe and the U.S., and managed project scopes involving HVAC, process equipment, clean/black utilities, automation, and data systems.

Ms Lavinia Lima, AstraZeneca (Emerging Leader)

Lavinia Lima is a Manufacturing, Science & Technology Specialist at AstraZeneca Nijmegen, and member of the site’s Innovation Hub, providing AI trainings and supporting the implementation of innovative solutions. She helps colleagues build trust and confidence with new technologies through communication and hands-on experimentation, focusing on impact and engagement. Before joining pharma, she worked for over five years in education, where she learned to deliver complex ideas clearly and effectively. She is also personally interested in sustainability and exploring how technology can be applied responsibly to create meaningful impact.

Mr Benjamin Morrow, CPI & Loughborough University (Emerging Leader)

Benjamin Morrow is a final year Product Design and Technology student at Loughborough University, who recently spent his placement year at Centre for Process Innovation (CPI), contributing to innovation-focused projects within advanced technology and applied research environments. His academic and professional interests span product development, digital innovation, and emerging technologies, with a particular focus on practical applications that bridge engineering, design, and industry collaboration. Alongside his studies, Benjamin has supported technical learning and prototyping activities, helping fellow students develop skills in specialised digital design and visualisation tools and leading skills-building workshops. Through his work with CPI and his academic background at Loughborough University, he brings a strong interest in how innovation and technology can be translated into real-world industrial and interactive solutions.

Mr Ollie Plant, WSP (Emerging Leader)

Ollie Plant is a Process Engineer at WSP specialising in multidisciplinary design across the chemicals, pharmaceuticals, and life sciences sectors. He has led and delivered both process and multidiscipline engineering workstreams across diverse projects, including biopharmaceutical facilities (front-end design), international site master planning and bioethanol waste utilisation (EPCM).

Dr Clare Rawlinson-Malone, Bristol Myers Squibb

Clare Rawlinson Malone is Executive Director, Site Lead for Moreton, and Head of Regulated Analytical Science and Operations at Bristol Myers Squibb. She leads a complex, multi functional site supporting product development and clinical supply, bringing together science, operations, and infrastructure to deliver medicines for patients. Clare has built her career across pharmaceutical development, with deep expertise in analytical science, formulation, and regulated testing. Since joining Bristol Myers Squibb in 2011, she has held a series of leadership roles of increasing scope and has played a key role in shaping the growth of the Moreton site, including the design and delivery of new laboratory capabilities aligned to sustainability and operational performance. Her leadership focuses on getting the best out of individuals and teams, rooted in her early career in academic research and teaching. She brings a practical, systems led approach to building inclusive, high performing environments, with a strong emphasis on innovation, resilience, and collective delivery.

Mr Andrew Sinclair, Biopharm Services

Andrew has over 30 years of design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance, and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. Before Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards, a Chartered Engineer, a Fellow of IChemE, and a Fellow of the Royal Academy of Engineering. He has been a coauthor of 3 articles in Pharmaceutical Engineering over the last 2 years, he was a lead author on the new baseline guide on Continuous Manufacturing of Biological Products, and participates in the Disposables Community of Practice (Disposables CoP).

Mr Euan Sutherland, CPI

Euan Sutherland CEng MIChemE is a Senior Process Engineer at CPI, where he leads the development of scalable, sustainable and cost‑effective manufacturing processes for oligonucleotides at the Medicines Manufacturing Innovation Centre (MMIC). He has a decade of industrial experience spanning process development, scale‑up, aseptic processing, continuous production, engineering design and commissioning and qualification. Before joining CPI, Euan spent over six years at Carl Zeiss Meditec as the technical lead and project manager for major GMP process improvements within a regulated medical device manufacturing environment. His work included developing new GMP processes, managing pilot‑plant feasibility studies across Europe, implementing validation strategies, facilitating FMEAs and introducing statistical control methods to resolve critical material issues. Earlier in his career, Euan developed continuous flow reactor technologies at AM Technology and managed feasibility studies for pilot‑scale chemical processes. He holds an MEng in Chemical Engineering from the University of Edinburgh and is a Chartered Chemical Engineer (CEng) and Member of IChemE. Across his roles, Euan has worked at the interface of innovation and GMP, helping organisations adopt new technologies while maintaining regulatory compliance and operational robustness.

Contact Us

If you require assistance or any further information, please contact Georgee Hancock on the below details.

Meet the Speakers

Guest Speakers

Contact Us

Website

Phone

Email