MAIN DUTIES & RESPONSIBILITIES Coordinate the validation of analytical methods to quantify drugs, anti-drug antibodies or biomarkers in biological matrices by ligand binding assays (ELISA, MSD) according to international guidelines.
Coordinate sample analysis projects, including regulated and non-regulated, pre-clinical and clinical studies.
Manage method development projects.
Deliver extensive and effective communication with sponsors and timely delivery of results.
Organize and line-manage laboratory personnel.
Effectively resolve technical and regulatory issues.
Actively support Senior Management and participate in strategic projects to optimize procedures.
REQUIRED PROFILE & QUALIFICATIONS PhD, MSc or BSc in biology or related subject.
Minimum 3-years experience in bioanalytical CROs.
Experience working with ELISA, MSD or other Ligand Binding techniques.
Experience in managing validation and sample analysis projects for determination of Immunogenicity and PK for pre-clinical and clinical studies.
Excellent level of English (Spanish – nice to have).
Experience working with cell culture techniques will be highly valued.
Deep understanding of international bioanalytical guidelines for PK and Immunogenicity assay validation, and experience working under GLP/GCP regulations.
Experience working with LIMS systems.
OTHER REQUIRED SKILLS Strong communication and organization skills, and capacity to work in teams.
Proactive and hands-on approach.
High level of motivation and enthusiastic personality.
WHAT IS OFFERED Opportunity to work and contribute to the success of an expanding CRO.
Solid scientific team with career growth opportunities.
Cutting edge laboratory with the latest technology.
International and multicultural environment in company based in Barcelona.
Diligent, professional organization, with a human touch.
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