Stuart Hadley

Lead the planning and execution of the CMC strategy for all pipeline products. Development, scale-up, technology transfer and validation of chemical processes for APIs. Oversight of drug substance manufacturing. Formulation development (including bioavailability enhancement techniques) and manufacturing for clinical supply. Management of IMP supply chain including clinical trial packaging, labelling and distribution. Contributing to overall regulatory strategy, authoring/reviewing/managing the generation of IMPD/IND Module 3 sections and equivalent regulatory filings; and responding to queries. Selecting and managing multiple CDMOs and consultants to meet company objectives.

Leadership of cross functional team responsible for CMC development of assets in early and late stage development through to commercialisation and life cycle management. Accountable for building a fully integrated supply chain from Active Pharmaceutical Ingredient (API) through to IV and Oral drug product manufacture, packaging and distribution via an outsourced model. Accountable for the assessment, selection, performance management and quality monitoring of all external partners involved in the production, manufacture and distribution of both IMP and commercial products, including contract negotiation, management of vendor costs and out of scope activities. Leading capacity management strategy and planning.

Operational lead of the CMC team building a fully integrated supply chain from Active Pharmaceutical Ingredient (API) through to IV and Oral drug product manufacture, packaging and distribution via an outsourced model. Responsible for the assessment, selection, performance management and quality monitoring of all external partners involved in the production, manufacture and distribution of both IMP and commercial products, including contract negotiation, management of vendor costs and out of scope activities. Leading capacity management strategy and planning.

Management of pre clinical & clinical phase outsourcing projects In the following areas; • Drug Substance and Drug Product development and manufacturing • Medical Device and Combination Product design, development & manufacturing • Comparator sourcing and manipulation • Primary and secondary clinical packing • Clinical distribution Lead contract negotiations for IPR critical technology contracts with Academic institutions, SMEs & MNCs Lead a team of Outsourcing Project Managers responsible for delivering a portfolio of technology contracts Recruitment, development and training of new outsourcing project mangers Part of Pharmaceutical Development Sourcing group Leadership team, accountable for setting the strategy and management of the group’s performance. Lead Safety, Health & Environment and Corporate Responsibility audits of suppliers. Maintain close relationships with key suppliers to give strategic steer for continuous improvement and supplier development As part of category team contribute to the development of the category strategy, through the analysis of spend and CRO performance data, as well as the provision of market and supplier intelligence Trained culture change facilitator and team effectiveness coach, leading tailored sessions developed to individuals and teams meet their potential and objectives.

Managed a large outsourcing portfolio to deliver specific project requirements in line with the category strategy. Procured commodity chemicals for internal development manufacturing and Drug Substance for commercial operations. Contract and scope change negotiations. Supplier Relationship Management Application of eProcurement tools.

Lead the analytical chemistry component of several development projects and represented analytical chemistry on project teams Line management of team consisting of 3 analytical chemists. Responsible for recruitment activities in analytical chemistry, including organising recruitment campaigns and interview programs as well as technical and competency interviewing