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Senior Scientist II

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Job Purpose

As a Senior Scientist II in our LBA/Immunoassay group, you will serve as the technical Study Lead ("Responsible Scientist") for a portfolio of ligand-binding and cell-based immunoassays. You will design and execute method development, validation, and routine sample analysis; manage small cross-functional teams; interact directly with clients; and ensure on-time, on-budget delivery of bioanalytical data in full compliance with GLP/GCP requirements.

Main Areas of Responsibility

  • Assay Leadership & Development
    • Act as Study Lead or Principal Investigator for ligand-binding (e.g., ELISA, MSD, DELFIA™) and functional immunoassays (e.g., cell-based reporter assays).
    • Design assay formats, establish acceptance criteria, and implement bridging strategies across assay platforms.
    • Lead full method lifecycle: feasibility → development → optimization → validation → transfer to routine testing.
  • Project & Resource Management
    • Create and maintain detailed study plans, GxP-compliant protocols, and risk assessments.
    • Coordinate reagent sourcing, lot qualification, and stability monitoring.
    • Allocate staff, instrumentation (MSD QuickPlex, Epoch microplate reader, SpectaMax), and consumables to meet client deliverables and revenue targets.
  • Client Engagement & Documentation
    • Serve as primary technical contact for study discussions, design reviews, and data interpretation meetings.
    • Draft and critically review study documentation: validation plans, assay reports, deviation investigations, and final study reports.
    • Present data summaries and troubleshooting recommendations in clear, client-facing reports and presentations.
  • Laboratory Compliance & Training
    • Ensure all laboratory activities adhere to GLP, GCP and internal SOPs; drive continuous improvement through audits and corrective-preventive actions.
    • Develop and deliver training modules on LBA/immunoassay best practices, data integrity, and new instrumentation.
    • Mentor junior scientists, provide hands-on guidance during assay execution, and uphold a strong culture of safety and quality.

Qualifications & Experience

  • Master's (preferred) or Bachelor's degree in Immunology, Molecular Biology, Biochemistry, or related field.
  • ≥5 years' hands-on experience in a regulated bioanalytical setting, with ≥3 years leading ligand-binding or immunoassay studies.
  • Demonstrated proficiency on one or more platforms: MSD (ECL), ELISA (colorimetric/fluorescent), DELFIA™, AlphaLISA, or similar.
  • Strong knowledge of GxP regulations (GLP, GCP, GCLP) and ICH bioanalytical guidance.
  • Exceptional written and verbal communication skills (English); proven ability to author technical reports and interact with clients.
  • Proficient in data analysis software (e.g., SoftMax Pro, Fit-for-Purpose validation tools, Prism).

Preferred Skills & Experience

  • Familiarity with ERP systems for timesheet and material-use tracking.
  • Track record of process improvements, cost optimization, and meeting demanding timelines.
  • Experience in cross-functional matrix teams, contributing to business development proposals and quotations.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

Senior Scientist II

Synexa Life Sciences
Macclesfield, UK
Full-Time

Published on 10/07/2025

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