Senior Scientist II (Project Leader)

Synexa Life Sciences; Macclesfield; On-site; GBP 50,000 - 65,000; Full time

Job summary

A leading biopharmaceutical company in Macclesfield is seeking a Senior Scientist II to serve as the technical Study Lead, managing a portfolio of ligand-binding and cell-based immunoassays. The candidate should have over 5 years of experience in regulated bioanalytical settings, with a strong focus on GxP compliance and client engagement. This role involves leading project teams and ensuring on-time delivery of bioanalytical data, along with mentoring junior scientists.

Qualifications

• 5+ years' experience in bioanalytical setting, 3+ years leading ligand-binding or immunoassay studies.
• Proficiency on platforms like MSD, ELISA, DELFIA.
• Strong knowledge of GxP regulations (GLP, GCP, GCLP).

Responsibilities

• Act as Study Lead or Principal Investigator for ligand-binding and functional immunoassays.
• Create and maintain detailed study plans and GxP-compliant protocols.
• Serve as primary technical contact for study discussions and design reviews.

Skills

Hands-on experience in a regulated bioanalytical setting

Exceptional written and verbal communication skills

Data analysis software proficiency

Education

Master's or Bachelor's degree in Immunology, Molecular Biology, Biochemistry

Tools

SoftMax Pro

Fit-for-Purpose validation tools

Job description

Overview

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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.