The Biotherapeutics Development Unit at GNF is seeking a senior scientist in bioanalytics with demonstrated experience in biological drug development with the following responsibilities:

•Development, validation and implementation of state of the art assays (flow cytometry, bioassay, PD, biomarker) to support biological products including antibody drug conjugate products.
•Interpret study results, evaluate data and draw relevant conclusions.
•Maintain good understanding of relevant novel assay technologies/ principles/ protocols in own discipline and good understanding of closely related areas.
•Identify complex problems (e.g. overall raw data quality, inconsistency of data/results, and appropriateness of study design/approach/technology) and propose creative and workable solutions.
•Manage lab/assigned area and assure quality of raw data in compliance with the guidelines (SOP, GLP, HSE, Novartis policies, etc.).
•Communicate knowledge obtained from external sources to the internal unit.
•Publish internally and/or externally if business needs; patent applications; review current literature in own discipline.
•Present scientific/technical work at internal/external meetings
•Write SOP’s, guidelines in his/her area where appropriate. Write summary document contribution (IB, IND, etc.) with guidance where appropriate.
•Establish close collaborations with other project team representatives in GNF and other Novartis bioanalytical laboratories. 

Education:

Ph.D. in immunology, biochemistry or related field, plus minimum of 3 years relevant experience.

Experience and technical skill sets:

•Extensive experience with flow cytometry and bioassay development and validation
•Experience with diverse biotherapeutics portfolio especially on antibody and antibody drug conjugate are desirable.
•Knowledge and experience in working to appropriate regulatory and quality guidelines (e.g. GLP).
•Good knowledge of scientific discipline and relevant laboratory tools and procedures. 
•Knowledge of problem-solving techniques.
•Involvement in cross-functional teams.
•Working knowledge of tools and processes used in drug development.
•Strong understanding of state of the art immunoassay and other bioanalytical techniques (and good knowledge/skills in PK/PD and Immunogenicity).
•General understanding of related bioanalytical techniques (e.g. LCMS, biacore), PK/PD modeling, drug metabolism, toxicology and clinical pharmacology.
•Good understanding of interactions and interpretation of PK, PD and immunogenicity data.
•Ability to present and report findings by means of IT tools.

Send CV/resume as attachment to the email address listed below (please include job code).