Development Scientist – Assay Development (Clinical Trials)

Overview

In this role you will lead the development and validation of molecular, virology, microbiology and immunology assays to support hVIVO’s business and client projects. You will manage multiple studies, mentor junior staff, and collaborate with cross-functional teams to ensure quality and timely delivery within regulated environments. You’ll engage with clients, contribute to lab capabilities strategy, and present data clearly to management and stakeholders. This is a hands-on, impact-driven position at a pioneering company shaping early-phase research.

Responsibilities

• Develop and validate assays to advance business potential
• Manage internal and client-driven research projects
• Prepare study protocols, data, and final reports for Clinical and hLab studies
• Communicate progress and risks to management and clients
• Plan budgets and resource needs for experimental work
• Generate large data sets and present findings to stakeholders
• Train and mentor junior staff on new technologies and processes
• Oversee operational delivery of multiple projects
• Coordinate with QA for timely audits of study documents and results
• Ensure SOPs, GMP/GLP/GCP standards and safety regulations are followed
• Contribute to publications and maintain laboratory documentation
• Maintain laboratories and ensure compliance with Health & Safety requirements
• Attend conferences and client meetings as appropriate

Key requirements

• PhD essential
• Experience in virology, microbiology or immunology essential
• Experience in assay development and validation in a commercial environment essential
• Experience of working with research teams to implement and deliver protocols
• Significant industry experience; operational management preferable
• Knowledge of GCP/GLP/ISO/GMP environments and regulatory guidelines is advantageous

• strong communication skills
• project and time management
• mentoring and training能力
• assay development and validation
• data analysis and presentation of complex data
• regulatory compliance knowledge (GCP/GLP/GMP)

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