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Offre d'emploi: scientist

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   . 09. octobre 2019
   . eysins, genève
   . life sciences
type d'emploi
   . placement fixe
   . 13367
   . coralyne saint-cirel, genève professionals health care & life sciences
   . 058 201 54 40
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description du poste

Purpose of the role:The key accountability for this role is to perform and report laboratory and project-basedactivities 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 and 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 activitiesin support to CMC and Nonclinical Pharmacology.- Support operational activities of in vitro pharmacology lab and CROs/CMOs, and takeactions as part of CMC Teams or Subteams.- Develop & qualify binding and potency assays to characterize the in vitro bioactivity of 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; andestablish reports following necessary quality standards (Good Scientific Practice) anddata management needs to fulfill submission relevant regulatory requirements.- Generate data for QTPP establishment, comparability and similarity ofproducts for in vitro pharmacology.- Provide support to assay technology transfer, and to create and updateregulatory CMC and Non Clinical packages.- General lab support and maintenance
Profile :- Scientific degree (PhD or M.Sc./Engineer + equivalent years of experience) inBiotechnology, Biochemistry, Biology, Pharmacology or related field- Fluency in English essential- Minimum 3 years of experience in R&D organization in Biopharma/Biotech companyon biological identification/characterization of biopharmaceutical drugs- Demonstrated successful track record in in vitro pharmacology (CMC and NonClinical) of biopharmaceutical drug development- Demonstrated assay development skills using several characterization techniques forbinding assays, with hands-on expertise in SPR (Biacore T200 and 8K). Experience with cell based functional assays is an asset


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Post Date: 10/09/2019 / Viewed 24 times
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