Scientist Bioassays in Geneva area

veröffentlicht
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Geneva area
Sektor
Life Sciences
Jobtyp
Temporary
Referenznummer
12637
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Telefon
058 201 54 40
jetzt bewerben

Stellenbeschreibung

Purpose of the role:

The key accountability for this role is to perform and report laboratory and project-based activities in an independent manner to support the in vitro pharmacology characterization, following necessary quality standards and timelines. Plan and execute binding and biological characterization assays in support to cQA assessment, assay development and qualification, QTPP establishment, clone/process selection, comparability and MoA evaluation of products. Analyze and record data, provide interpretation of results & write protocols, reports and contribute to CMC and Nonclinical sections of dossiers submitted to regulatory agencies.

 

Key tasks and Responsibilities:   - Execute the in vitro pharmacology planning of laboratory and project-based activities in support to CMC and Nonclinical Pharmacology. - Support operational activities of in vitro pharmacology lab and CROs/CMOs, and take actions as part of CMC Teams or Subteams. - Develop & qualify binding and potency assays to characterize the in vitro bioactivity samples at different stages of development (Biacore, ELISA, MSD, FACS, cell based functional assay) - Understand project strategy and highlight risks and issues, propose mitigation. - Write/revise SOPs, study protocols; analyze, record and interpret results; and establish reports following necessary quality standards (Good Scientific Practice) and data management needs to fulfill submission relevant regulatory requirements. - Generate data for QTPP establishment, comparability and similarity products for in vitro pharmacology. - Provide support to assay technology transfer, and to create and update regulatory CMC and Non Clinical packages. - General lab support and maintenance

 

Professional skills and Experience - Minimum 3 years of experience in R&D organization in Biopharma/Biotech company on biological identification/characterization of biopharmaceutical drugs - Demonstrated successful track record in in vitro pharmacology (CMC and Non Clinical) of biopharmaceutical drug development

 

- Demonstrated assay development skills using several characterization techniques such as binding assays, with hands-on expertise in SPR (Biacore) methodology, and cell based functional assays. (e.g. FACS, Biacore, ELISA, MSD; signaling and phenotypic bioassays) - Significant exposure to CMC assay qualification and validation, and comparability study exercises - Exposure to biotech manufacturing operations and relevant in vitro pharmacology