MSAT Analytical Development Lead - Oncology/Neurology

Servier; Suresnes; Híbrido; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Servier is seeking an MSAT Analytical Technologies Expert (Neuro Onco) to lead analytical method lifecycle management for Oncology/ Neurology oral dosage forms. You will develop, validate, transfer methods and troubleshoot at CMOs and internal sites, ensuring compliance and regulatory readiness.

Reporting to the Oncology/Neurology MSAT lead, you will coordinate cross-functional teams, support regulatory submissions, and mentor junior scientists while contributing to global manufacturing

Formación

• Ph.D. in Analytical Chemistry or related field with 5 years of experience in oral dosage products.
• Alternatively a Master’s degree with 7 years of relevant experience.
• Experience drafting analytical sections for regulatory submissions (MAA/NDA/Variations).

Responsabilidades

• Act as analytical SME for commercial Oncology/Neurology Products (Oral Dosage forms).
• Oversee analytical activities at CMOs and internal sites.
• Manage lifecycle of analytical methods: development, validation, transfers, releases, stability.
• Collaborate with internal sites to support lifecycle management.
• Review deviation and OOS/OOT investigations at CMOs and internal sites with QA/QC.
• Support regulatory filings and respond to health authority queries.
• Represent analytical function in project team meetings.
• Participate in internal virtual plant and joint technical team meetings.

Conocimientos

Analytical chemistry

Method development

Method validation

Method transfer

Regulatory filing

Statistical analysis

Project management

Cross-functional collaboration

Communication skills

English proficiency

Educación

Ph.D. in Analytical Chemistry

Master's degree in related field

Herramientas

Minitab

JMP

Descripción del empleo

Servier is seeking an MSAT Analytical Technologies Expert (Neuro Onco) to lead analytical method lifecycle management for Oncology/ Neurology oral dosage forms. You will develop, validate, transfer methods and troubleshoot at CMOs and internal sites, ensuring compliance and regulatory readiness.

Reporting to the Oncology/Neurology MSAT lead, you will coordinate cross-functional teams, support regulatory submissions, and mentor junior scientists while contributing to global manufacturing