Senior Scientist II

Role Overview

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.

Key Responsibilities

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.

Required Qualifications

• 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.