Senior Scientist II
| Posting date: | 23 July 2025 |
|---|---|
| Hours: | Full time |
| Closing date: | 22 August 2025 |
| Location: | Macclesfield, Cheshire |
| Remote working: | On-site only |
| Company: | Synexa Life Sciences |
| Job type: | Permanent |
| Job reference: |
Summary
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.
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.