Wesley Heaton

Head of Technical Operations; through outsourced partners, accountable for process, formulation & analytical development, manufacture and supply of small proteins and biological therapies from development candidate through to commercial supply.

Supporting Biotech and Pharma businesses Globally in Development, Commercialisation and Lifecycle Improvement.

• Head of a small team which provides pharmaceutical leadership support for commercial product manufactured both in and outside of Mundipharma’s Independent Associated Companies. This support is broad and is inclusive of expertise in the fields of technical, quality, engineering, supply chain, lean six sigma and overall program management and covers multiple dose forms and manufacturing and testing processes (API, Oral Solid Dose, Sterile Processing, Vial Filling, Respiratory Devices, Lyophilisation). • Relationship management of CMOs and consultancies is part of the team’s remit. This has required further development of a key strength of building high performing cross functional teams and relationships with operational and senior management teams to help resolve disputes and issues. This has included initiating manufacturing strategies, exiting suppliers, resolving performance issues and negotiating cost of goods. • Held promoted accountability as Global (Ex US) Head of Technical Services for 5 months, effectively integrating development and commercial technical teams Key Achievements: • Working in partnership with the commercial team, led the Flutiform K-Haler team to achieve product launch in Europe ahead of schedule. K-Haler is a complex 13 component device (12 plastic and 1 drug product canister) and requires three CMOs and multiple expert consultancies to support the plastic injection moulding, device assembly as well as device and pharmaceutical testing.

• Head of the Technical Function (approx 40 staff) at the Worthing Primary Site and a key member of the Site Leadership Team. Was a key leader in the design and the execution of an accelerated site closure program. • Held promoted responsibility (2016/7) as Deputy Site Director and FDA Remediation. • Accountable for technical support, continuous improvement and change control/validation across 14 stages of Manufacture. This was inclusive of large scale fermentation/extraction processes as well as classical chemical manufacture. The team worked closely with R&D as well DP customers at formulation sites (16 sites worldwide). • The team were also responsible for the integration of Capital Projects (multi million pound investments) to the site and led the workstreams to restart manufacture post FDA inspection in July 2016. Key Achievements: • Rebuilt and restructured the Technical Function recruiting in excess of 40 people over a 4 year period; this was achieved by adopting strategic workforce planning, taking advantage of talent management processes and building a pipeline of talent through strategic relationships with two universities and engineering consultancies. By setting the vision and implementing effective management, the team moved from being only required for operations troubleshooting to having gained full technical accountability across all of the sites products and credibility with our worldwide customers. • Led the team through an incredibly difficult period of change from a 9-point FDA form 483 (Jul-15) and subsequent warning letter (Jul-16), stoppage of manufacture, FDA remediation and multiple inspections (internal and MHRA) to enable manufacture restart. I then led the team response of exiting GSK with pride where the team led and supported decontamination, decommissioning and technology/knowledge transfer. 95% of the team attained more senior positions internally and externally with barely a break in employment.

Responsible for tracking and directing the development of potential new R&D products to ensure manufacturability, sustainability and regulatory matters are fully considered and are acceptable to Global Manufacture and Supply (GMS) prior to validation in commercial facilities. Key Achievements Developed technical strategy for the launch of small volume products Led site New Product Introduction Blitz events Developed Business Case for 2nd Generation synthesis of a pre-launch product and obtained buy in from senior stakeholders

Key member of a global technical team focused on the delivery of the GSK Factory of the Future. • Defined the Sustainability Strategy for the Asia-Pacific and Japan region and facilitated the vision setting for two manufacturing sites in Singapore • Completed the Carbon Footprint assessment (all scopes) for the two Singapore manufacturing sites and tracked project progress using Lean Sigma methodology • Developed Carbon Footprint tools for chemical processes which are now being applied across the whole of GSK • Led sustainability projects all the way from idea generation (concept study) to proof of concept and business case development and then to scale-up and implementation. These projects are delivering significant environmental and financial benefit. • Key person in employee engagement, outreach programmes and educational activity • Led the Singapore Sustainable Manufacture team for 3 months

Lead Chemist for the cGMP manufacture of two commercial products and the Technology Transfer of a complex six stage process to a third party manufacturer. • Track record of successfully working with R&D, 3rd party suppliers and our secondary customers to investigate multimillion pound issues and implement suitable solutions • Track record of driving people development through site wide initiatives • Line Managed Industrial Placement students and led cross-functional teams • Responsible for technical documentation such as, COSHH assessments, Campaign Reports, Control Parameter Documents, Laboratory Procedures and Batch Record Documents

Post-doctoral research focusing on the identification, synthesis and optimisation of biologically active targets. • Three patents and three articles have been published in the scientific literature

PhD with Prof. Billy Kerr and in CASE collaboration with Celltech (USB)