Development Scientist - Assay Development (Clinical Trials) at hVIVO Services Limited | GB | Rezi

Development Scientist - Assay Development (Clinical Trials) at hVIVO Services Limited

Development Scientist - Assay Development (Clinical Trials)

hVIVO Services Limited · GB

Today

Development Scientist - Assay Development (Clinical Trials)

hVIVO Services Limited · GB

14 hours ago
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About the Role

hVIVO is seeking a Development Scientist to join their team, responsible for developing and validating molecular, virology, microbiology, and immunology assays. This role will also lead R&D client projects and contribute to business and lab capabilities development, with direct client engagement.

Responsibilities

  • 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.

Requirements

  • Proven experience of being able to prioritise and deliver multiple activities in-line with the agreed strategy.
  • Ability to effectively communicate progress and risks to management.
  • Demonstrate the ability to work independently, managing time efficiently and analysing complex data sets to compile into presentable formats.
  • Experience of training and mentoring junior staff.
  • Experience of the management of the operational delivery of their projects.
  • Strong communication skills, keeping management informed of progress in project delivery.
  • Experience in oral presentations and written outputs would be an advantage.
  • 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.
  • 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.

Skills

  • Assay development
  • Assay validation
  • Molecular assays
  • Virology assays
  • Microbiology assays
  • Immunology assays
  • R&D project leadership
  • Client engagement
  • Data analysis
  • Time management
  • Training
  • Mentoring
  • Project management
  • Communication
  • Oral presentations
  • Written outputs
  • Quality management systems (GCP, GLP, ISO, GMP)
  • Regulatory guidelines
  • Good Clinical Practice (GCP)
  • Good Clinical Practice for Laboratories
  • Research protocol implementation

Location

  • Canary Wharf, E14

Work Type

  • Onsite
  • Full-time

Experience Level

  • Significant industry experience
  • Operational management preferable

Education Level

  • PhD

About the Company

  • hVIVO is a dynamic and pioneering global player in the pharmaceutical early phase research sector.
  • hVIVO 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.