MSAT Analytical Expert – Cardio/Metabolism | 20% Travel

Servier; Suresnes; Sur place; EUR 100 000 - 140 000; Plein temps

Résumé du poste

Servier is seeking an MSAT Analytical Technologies Expert (Cardio-Metabolism) to lead analytical support across CMVD products. You will oversee method lifecycle management, transfers, validation, verification and troubleshooting at external CMOs and internal MSAT teams, ensuring quality and regulatory readiness.

The role requires a Ph.D. or equivalent experience in analytical chemistry, strong knowledge of regulatory submissions, and the ability to collaborate across diverse sites.

Qualifications

• PhD in Analytical Chemistry or related discipline with 5 years of relevant experience, or Master’s with 7 years in Oral Dosage products.
• Experience with analytical method lifecycle management, transfers, validations and troubleshooting.

Responsabilités

• Serve as analytical SME for CMVD products and oversee method lifecycle management.
• Lead method transfers to CMOs and internal sites.
• Manage analytical life cycle activities: development, validation, control strategy, transfers, release and stability testing.
• Collaborate with QA/QC and regulatory teams for filings and inquiries.
• Review deviation events and OOS/OOT investigations at CMOs and sites.
• Draft/review analytical sections of regulatory submissions (MAA/NDA and variations).
• Represent analytical in project teams and cross-functional meetings.
• Participate in internal plant and technical team discussions.

Connaissances

Analytical Chemistry

Method development

Validation

Regulatory submissions

CMC knowledge

Method transfers

OOS/OOT investigations

Statistical methods

Minitab/JMP

English communication

Project teamwork

Formation

PhD in Analytical Chemistry

Master's degree in Chemistry/Pharmaceuticals

Outils

Minitab

JMP

Description du poste

Servier is seeking an MSAT Analytical Technologies Expert (Cardio-Metabolism) to lead analytical support across CMVD products. You will oversee method lifecycle management, transfers, validation, verification and troubleshooting at external CMOs and internal MSAT teams, ensuring quality and regulatory readiness.

The role requires a Ph.D. or equivalent experience in analytical chemistry, strong knowledge of regulatory submissions, and the ability to collaborate across diverse sites.