Development Scientist ( Assay Development )

hVIVO ,
London, Greater London

Overview

Job Description

Overview hVIVO is a dynamic and pioneering global player in the pharmaceutical early phase research sector, and has been recently developing a strong discovery (research and development) focus to investigate human disease to help find better treatments, faster. We are always interested to hear from similarly dynamic and pioneering individuals who share our vision to better understand the more precise nature of human disease and to really make a difference. The Development Scientist will be part of a team of scientists who are responsible for the development and validation of assays in line with hVIVO corporate objectives and priorities. The Development Scientist should have a strong understanding of assay requirements from a quality, operational, scientific and economic perspective. Experience in commercialising assays through their productisation would be an advantage. The Scientist should have proven experience of being able to prioritise and deliver multiple activities in-line with the agreed strategy and be able to effectively communicate progress and risks to management. They should be able to demonstrate the ability to work independently, managing time efficiently and analysing complex data sets to compile into presentable formats. They should have strong communication skills, keeping management informed of progress in project delivery. Experience in oral presentations and written outputs would be an advantage. The Development Scientist should have a good understanding of and worked in an environment governed by a quality management system (GCP, GLP, ISO, GMP) for over 2 years. Specific experience of working to regulatory guidelines in compliance with Good Clinical Practice and Good Clinical Practice for Laboratories would be an advantage. Main Responsibilities The core responsibilities are: * Provide scientific expertise and delivery in the development and validation of assays to enhance hVIVO business potential; * Be responsible for the delivery of internal and client contracted research projects; * Prepare and review study protocols, data and final reports for both Clinical and hLab studies * Report analysed data within the department, to clients and to other divisions, as required * Manage time effectively to meet competing demands, ensuring that work is prioritised and that outputs are delivered to defined deadlines; * Establish budgets and determine resource needs for experimental work; * Provide regular updates on progress to management, compiling large data sets into presentable formats; * Liaise with the QA department to ensure timely auditing of study documents, study results and routine system procedures; * Ensure all work, where appropriate, maintains compliance with Good Clinical Practice and Good Clinical Practice for Laboratories, all relevant Standard Operating Procedures (SOPs) and company standards and guidance; * Assist in writing and reviewing publications to showcase hVIVO research in appropriate peer reviewed journals; * Review hVIVO SOPs regularly to ensure scientific robustness and/or change in regulatory guidelines; * Assist in the maintenance of the laboratories and ensure all procedures are performed according to Health & Safety regulations; * Attend conferences, client meetings and lectures as appropriate Skills & Experiences * BSc and PhD * Demonstration of considerable knowledge/expertise within relevant discipline * Experience of working directly with research teams to implement and deliver research protocols * Experience in assay development and validation Not ready to apply? Connect with us for general consideration.