Leading European bioanalytical CRO based in Barcelona (Spain) is looking for a Study Director to expand its Large Molecule team, which provides bioanalytical services to the pharmaceutical and biotechnological industries worldwide
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
- Deep understanding of international bioanalytical guidelines for PK and Immunogenicity assay validation, and experience working under GLP/GCP regulations.
- Experience working with LIMS systems.
- Experience working with cell culture techniques will be highly valued
- Excellent level of English (Spanish – nice to have).
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.