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Hobson Prior are seeking a Principal Scientist to join a world-wide healthcare organisation whose products and services are used in the therapy and care of critically ill patients. This is a permanent position located in Switzerland.
- You will supervise assay development and qualification activities, provide support to technology transfer and assay validation for GMP compliant batch release, comparability and stability studies.
- You will ensure sourcing of essential resources and establish contracts at CRO/CMOs.
- To deliver scientific expertise and take actions from CMC, Nonclinical Pharmacology and Biosimilars Development Teams.
- You will follow world-wide guidelines; necessary quality standards and data management needs to achieve regulatory requirements.
- To provide nonclinical pharmacology knowledge to biosimilar development and knowledge on biological mechanisms of action of drugs in support of similarity and extrapolation of indications.
- To organise and guide experimental work done internally or externally.
- To analyse, assess and interpret results, establish report templates, review and approve study protocols and CMC and nonclinical pharmacology result reports.
- You will support cQA assessment and QTPP establishment for biosimilars products.
- Assess the overall similarity of the products' biological activity.
- You will assess product analytical quality data for its relevance at functional level for potential impact on safety and efficacy in the clinic, propose and implement justification packages in support of similarity and extrapolation of indications.
- Any other assigned duties.
- Fluency in English essential, both oral and written.
- Achieve organizational focus on key priorities; demonstrate good judgment and business maturity to make sound decisions.
- Create a culture of high performance, team orientation, accountability and commitment.
- Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field.
- Industry and academic experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology, with a strong knowledge on the different mechanisms of action of biologics and their indications.
- Minimum 10 years of relevant experience in R&D of biopharma/biotech industry, including at mid-management level.
- Excellent knowledge and experience with in vitro binding and potency bioassays using recombinant and primary cells and ex vivo/in vivo models to evaluate structure-function relationship, disease specific mechanisms of actions and PD biomarkers of biologics.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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