MSAT Scientist

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.

Key Responsibilities:

1. Lead technology transfer projects to establish robust and compliant manufacturing processes and associated control strategies.
2. Maintain in-depth knowledge of manufacturing processes throughout the product lifecycle.
3. Author, review, and approve technical documents, including batch records, sampling plans, SOPs, risk assessments, study protocols, and technical reports.
4. Provide first-line technical support to manufacturing, ensuring compliance with relevant instructions and quality requirements.
5. Enhance process understanding by identifying key sources of variability and root causes of product and process failures.
6. Manage change reviews and implementation, risk assessments, quality investigations, impact assessments, and CAPAs within cross-functional teams.
7. Plan and organize training sessions for manufacturing personnel.

Qualifications & Skills:

1. Bachelor's or Master’s degree in Life Sciences (Biology, Chemistry, or related fields), Dipl. Ing., M.Sc., B.Sc., or equivalent.
2. Minimum of 3 years of experience in the diagnostics field, with expertise in biology, biochemistry, immunology, and automation.
3. Strong scientific and technical expertise in the Diagnostic/Pharmaceutical industry.
4. Native proficiency in French or German, with at least basic knowledge of the other language, and fluency in English.