Development Scientist - Assay Development (Clinical Trials)

Development Scientist - Assay Development (Clinical Trials)

hVIVO

London, United Kingdom

hVIVO are seeking a Development Scientist to join our team of scientists who are responsible for the development and validation of molecular, virology, microbiology and immunology assays in line with hVIVO corporate objectives and priorities.

The Development Scientist will also lead bespoke R&D client projects as part of lab services and contribute to the business and lab capabilities development strategy, engaging directly with clients as required.

The candidate 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 experience of training and mentoring junior staff as well as the management of the operational delivery of their projects. 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. They should have a good understanding of and worked in an environment governed by a quality management system (GCP, GLP, ISO, GMP). 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;
• Provide training and mentoring for junior staff and new technologies and processes within the lab
• Management of the operational delivery of multiple projects across the team
• 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;
• Management and 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

• PhD essential
• Experience in virology, microbiology or immunology is essential
• Experience in assay development and validation in a commercial environment is essential
• Experience of working directly with research teams to implement and deliver research protocols
• Significant industry experience, operational management preferable
• Demonstration of considerable knowledge/expertise within relevant discipline