To direct and deliver all R&D aspects of the vaccine programmes within agreed timelines and budget in alignment with the company's R&D and commercial strategy. • In consultation with the R&D Director, CTO and CEO, create and manage the development plans for assigned programmes.• Establish key programme milestones and using appropriate planning tools create a clear critical path route to achieving these milestones with associated timelines, highlighting risks and suggested mitigation options.• Create and manage a budget around each programme.• Identify and prepare non-dilutive grant funding applications aligned with the financial and strategic needs of the programmes.• Ensure that all aspects of GLP, GMP, GCP and GCLP are adhered to where necessary and appropriate, and are aligned with the relative stage of product development to ensure the successful progression of the programmes.• Identify and consult with key opinion leaders in the disease areas of each programme to ensure that we receive and implement good guidance to add value to the product candidates.• Select and manage suitable Contract Organisations (CMOs and CROs) to support progress of the programmes, ensuring that the contract organisations are fit for purpose i.e. can support programme requirements in terms of expertise, cost, quality and timelines. • Take part in the regular review of the Quality System, suggesting updates and improvements to current SOPs and suggest additional SOPs that are required to support the company’s progressive development activities and responsibilities.

Manage the regulatory, manufacturing, licensing activities and operation budgets for the process of obtaining approval for AQIX®RS-I as a novel liquid formulation for the organ transplantation as Class III medical device and as a investigational medicinal product for use as a blood expander therapeutic for the treatment of hypovolemia and/or the treatment of sepsis. I was responsible for the design and installation of a EU GMP, ISO 9001/SO 13485 compliant Quality Management System within Aqix Ltd, whilst acting as the scientific, GMP, regulatory and technical resource for all subcontractors involved in the manufacture and distribution of AQIX®RS-I. Establish collaborations between Aqix Ltd and academic or industry partners to progress AQIX®RS-I in model systems and clinical investigations by acting a primary company representative a meetings and conferences.

• The implementation of a Quality Management System that includes the use of Training Records, Standard Procedures, Study Protocols, Reports, IQ/OQ, as well as specific systems for Change Control, Complaints and Recalls, Deviation Management, CAPA, Risk Assessment and Statistical Process Control.• Auditing of EU and overseas contractor manufactures and suppliers to ensure compliance to required standards (e.g. EU GMP, ISO9000, CFR Part 210/211).• Performing internal audits and investigations relating to OOS and protocol deviations as required by CAPA systems.• Application of systems for the monitoring and improvement of the Key Performance Indicators of the Quality System to increase both productivity and quality standards.• Preparation, review and approval of Policy Documents, Technical/Quality Agreements, SOPs and reports.• Review of Batch Manufacturing Records, analytical specifications, and GMP documentation to support the contracted QP.• Management, review and approval of all deviation related to GMP manufacture.• Preparation of regulatory dossiers for submission to the MHRA, EMEA, and FDA.• Supervision, Training and Mentoring of a team of 3 QA Officers (including 1 Unblinded CRA) and 3 QC Analysts.• Delivering annual GMP training to staff throughout the company.• Liaising with Contract Research Organisations and contract manufacturing sites for evaluation of study protocols, process qualification and assay validation.• Act as Unblinded Project Manger for Phase IIb Clinical Trial.