+34 93 241 93 76

Study Director -Large Molecules 500 views3 applications

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.
Apply for this job
Share this job