Senior Research Scientist

Our client is a mid-size research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, they provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Their full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements.

The Senior Research Scientist is responsible for developing assays to quantify biotherapeutics, biomarkers and anti-drug antibodies (ADA) in biologic matrices using various assays platforms. Is responsible for the supervision of analysts and QC auditors in his team, troubleshooting activities and fulfill Principal Bioanalytical Investigator responsibilities.

Role:
• Develop ligand binding assays for the determination of PK, biomarker and anti-therapeutic antibodies using various assay platforms;
• Applies specific technology platforms such as Mesoscale Imager, Luminex 200, Bio Tek plate reader and plate washer/dispenser
• Act as a Principal Investigator on validation or sample analysis projects; includes oversight of the technical, scientific and regulatory conduct;
• Coordinate all aspects of studies to meet deliverables;
• Provide updates and responses to Sponsor questions;
• Promote and lead scientific initiatives in the bioanalytical laboratory;
• Contribute to the visibility of the Ligand Binding Assay Group, via presentation of posters and/or oral lectures at conferences;
• Prepare specific bioanalytical Method SOP, Validation Plan, Validation Report and Bioanalytical Reports;

Requirements:
• Ideally a PhD with at least 5 to 8 years of experience in the development of ligand binding assays and coaching of laboratory personnel in a regulated environment

EEO – M/F/D/V