Principal Scientist

Exciting Medical Devices Development company seeks an experienced and enthusiastic Principle Scientist to support the company's commercialisation programme, to work within the Assay Development Team to develop the Company's diagnostic platform and associated assay menu. About the role: The suitable candidate must have the ability to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities. A great capacity and desire for taking on new responsibilities and challenges is essential as the company grows and projects expand. Working professionally with chemists, physicists and engineers, the post holder will be responsible for supporting the development of in-vitro diagnostic (IVD) products in the areas of sample processing and nucleic acid testing. The role requires the planning and execution of experiments and development tasks in addition to liaising with suppliers, partners and facility managers. The role also includes the support and mentoring of Assay Team Research Scientists and Technicians and to support the Team Lead with administrative duties, attending meetings and compiling reports where required. Duties may include: * Plan, and where required perform, general molecular and microbiology-based tasks, including assay design, sample processing, DNA/RNA extraction, PCR, fluorescence microscopy, tissue culture, bacterial culture and quantification. * Record results accurately and in a Laboratory Book in accordance with Company policy and GDP. * Report to and support the Team Lead, participate in lab meetings, document review and lab book review. * Be able to follow and write SOPs and review those written by junior staff. * Support the planning and execution of experiments by others in the team and across project teams as required. * Support the transition of infectious disease assays from research into development. * Support the transfer and optimisation of molecular assays from bench top to bespoke platforms. * Support the Validation and Verification activities of the project team. * To provide support to the commercialisation activities of the company. * Comply with and help to enforce safe laboratory practices. * Comply with regulatory requirements of working with clinical samples. * Effectively interact with other Technical and Development teams including those of external partners. * Record and interpret results to present to project groups and senior management. * Represent the company by presenting results and project updates to external parties. * Support the Team lead and Business development team in grant writing and reporting. * Work within the Company's Quality Systems and Policies in line with ISO13485 standards. * Comply with QA standards and policies and ensuring that targets are achieved. * Comply with and help to enforce safe laboratory practices. * Work within the standards required to maintain HSE approval for handling CL2 and CL3 organisms. Skills and experience * A PhD with significant experience in molecular biology. * Significant commercial/industrial experience in developing IVD assays and in particular MDx assays on established commercial platforms. * GLP and ISO 13485 standard experience. * Previous experience of assay validation. * Previous experience working with clinical samples including the ethical implications. * Knowledge of safe laboratory practice and containment. * Previous experience supervising scientist or PhD students * Previous experience running projects. * Ability to work with of scientists to accomplish research project objectives and goals. * Meticulous record keeping. * A willingness to learn new techniques and a readiness to understand technologies from multiple disciplines. * Maintain confidentiality at all times. * Excellent communication/IT skills and ability to work in a changing environment on complex projects. * Outstanding teamwork and ability to interact with external and internal partners on fast paced projects. * Be eligible to work full time in the UK without restriction. * Previous experience working with HPV. * Previous experience of molecular diagnostics for infectious diseases. * Previous experience of lab on a chip and/or cassette/cartridge based MDx platforms. * Knowledge of statistics and advanced data presentation. * Previous experience of working in a microbiology lab and with BSL II and BSL III organisms.