senior scientist physicochemical analytics à Geneva area

publié
contact
Coralyne Saint-Cirel, Genève Professionals Health Care & Life Sciences
type d'emploi
permanent
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job details

publié
lieu
geneva area
secteur
Life Sciences
type d'emploi
permanent
référence
12080
contact
coralyne saint-cirel, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Main Responsabilities: 

- Provide guidance across projects on scientific and quality strategy applicable to analytics - Oversee CQA assessment and establishment of analytical similarity corridor (Quality Target Product Profile) using state of the art analytical assays - Interpret complex physicochemical data and assess their relevance at the functional level - Develop with scientists within Analytical Team and/or CROs stage-adapted analytical toolbox for manufacturing clone selection, process development, demonstration of analytical similarity at large scale and assessment of comparability. - Create and maintain detailed, ambitious yet realistic analytical testing plans ensuring rigorous and timely decision making that maintains rapid project progression - Manage direct/indirect interaction with Analytical Teams and external CROs/CMOs respectively, including setting expectations and monitoring progress - Prepare statistical analysis plans and similarity assessments with CMC Statistics - Work with project managers to review submissions including Briefing Book, IND, IMPD etc. prior to regulatory consultations - Understand project strategy and highlight risks and issues, propose mitigation - Build and maintain scientific excellence in analytical research

 

Education & Languages - Advanced scientific degree or equivalent with degree in biochemistry, bioanalytics and post grad training in respective fields - Fluency in English essential, both oral and written; additional languages (German or French) are an asset

Professional skills and Experience - Minimum of 10 years experience in R&D in biopharma/biotech industry - Specific experience of either of the following will be considered an advantage: o streamlining phase specific method development and validation (including method transfer) utilizing QbD and DoE principles o Significant exposure to biotech manufacturing operations and related analytics