Scientist - Technical Development

vor 3 Wochen

Basel, Schweiz Global Personal Partner Vollzeit

**EINFÜHRUNG**:
Our profession and our passion "HR Management."

Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland.

For our client, an international orientated company in Basel, we are looking for a reliable and motivated (M/F/d)

**Scientist - Technical Development 100%**:
**AUFGABENBESCHREIBUNG**:
**Major Activities
Responsibility as Microbiology Expert - Pyrogen Testing
- Supports project teams in BET release, stability, and IPC testing incl. AS, JS, VS, AM, and analytical batch record reviews
- Supports in the setting of BET specifications for drug substances, drug products, and vehicles
- Review BET method suitability test protocols and reports including corresponding analytical raw data
- Supports method transfer and reviews transfer protocols and reports (internal and external)
- Writes/reviews risk assessments in case of endotoxin contaminations or deviations
- Supports project teams in LER-related topics
- Provides expertise for beta-glucan testing analytics
- Reviews SOPs/WPs
- Supports answers to health authority requests (BET and MAT-related HA requests)
- Builds strong collaboration and standards with external testing laboratories
- Key Performance Indicators
- Meet quality and timelines in the area of responsibility
- Feedback from team members
- Act in accordance with standards in particular cGMP, ethical, health safety and environment (HSE), and information security (ISEC)
- KPI metrics and due dates in 1QEM, TQW, etc

**ERFORDERLICHES PROFIL**:
Requirements
- Minimum: Ph.D., diploma, bachelor or master in microbiology/biotechnology (or related science)
- Languages: Fluent in English required (adequate knowledge oral & written)
- Experience/Professional requirement: - Relevant working experience (min. 1 - 3 years) within the pharmaceutical industry / GMP environment
- Communication skills to sufficiently address the need, and purpose of needed queries
- Detailed knowledge of MS Office
- Good organizational skills

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