MSAT Scientist
vor 4 Wochen
Axepta is looking for an MSAT Scientist on behalf of one of its prestigious clients in the medical devices industry.
Position Overview:
The MSAT Scientist will be responsible for leading technology transfer, supporting manufacturing processes and products, and contributing to overall technical improvements.
- Lead technology transfer projects to establish robust and compliant manufacturing processes and associated control strategies.
- Maintain in-depth knowledge of manufacturing processes throughout the product lifecycle.
- Author, review, and approve technical documents, including batch records, sampling plans, SOPs, risk assessments, study protocols, and technical reports.
- Provide first-line technical support to manufacturing, ensuring compliance with relevant instructions and quality requirements.
- Enhance process understanding by identifying key sources of variability and root causes of product and process failures.
- Manage change reviews and implementation, risk assessments, quality investigations, impact assessments, and CAPAs within cross-functional teams.
- Plan and organize training sessions for manufacturing personnel.
- Bachelor's or Master’s degree in Life Sciences (Biology, Chemistry, or related fields), Dipl. Ing., M.Sc., B.Sc., or equivalent.
- Minimum of 3 years of experience in the diagnostics field, with expertise in biology, biochemistry, immunology, and automation.
- Strong scientific and technical expertise in the Diagnostic/Pharmaceutical industry.
- Native proficiency in French or German, with at least basic knowledge of the other language, and fluency in English.
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