Acting Head of Bioanalytical Development - Switzerland
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- Our company is a Swiss drug discovery and development company, focused on the creation of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer.
- The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.
- Four of these compounds are currently in early clinical development with the anti-IFNg monoclonal antibody program, most advanced, at Phase 2/3, for the orphan drug indication Hemaphagocytic Lymphohistiocytosis (HLH).
- Our company is currently seeking an acting Head of Bioanalytical Development who will report to the Head of Bioprocess Department and will provide overall responsibility for the Bioanalytical development unit activities.
- Resource planning and staff management of 3 FTE
- Responsible for project management with external CROs for potency assays
- Responsible for bioanalytical method development and qualification (potency assays)
- Responsible for maintaining and optimizing quality system within the unit
- Responsible for Quality Control of product potency
- Manage planning for time point testing for all stability and giving set studies for all projects including QC verification
- Ensure timely delivery of QA audited time-point testing data for all stability and giving set studies for all projects
Skills and competencies:
- Minimum Master’s Degree in Biotechnology, Biology, Biochemistry, Chemistry or equivalent
- Experienced in method development of receptor binding assays and cell based potency assays for therapeutic antibodies e.g. ADCC, ADCP
- Experienced in method qualification and validation
- Excellent knowledge of ELISA, FACS and HTRF readout technologies and data interpretation
- Knowledge of GxP Quality systems
- Experience of people management
- Excellent organizational, written and oral communication skills in English are required, with language including French, preferred.
- Swiss resident or EU national