MSAT Oral Solid Drug Product Expert CMVD Monotherapy

About the role

Within Servier’s Manufacturing Science and Analytical Technology (MSAT) organization, the Oral Solid Drug Product team provides technical stewardship across the lifecycle of oral solid dosage forms. The Oral Solid Drug Product Expert for CMVD monotherapy acts as the subject‑matter expert for cardio‑metabo‑venous disease products, supporting both internal sites and external CMOs.

Key responsibilities

• Own technical oversight of manufacturing processes for CMVD monotherapy products at Servier sites and partner CMOs, participating in virtual plant teams.
• Lead cross‑functional technical teams, manage meeting agendas, drive alignment on timelines, supply impact and budgets.
• Conduct deviation investigations, root‑cause analysis and define CAPA actions, ensuring robust closure and knowledge transfer.
• Drive technology transfers, scale‑up changes, process performance qualification (PPQ) and launch readiness across global sites.
• Author and review CMC sections of regulatory submissions and respond to health‑authority queries.

Required profile

• Bachelor’s (minimum) or Master’s/PhD in Pharmaceutical Sciences, Chemical Engineering or related field.
• 5‑10 years of experience in oral solid drug product formulation, process development and manufacturing support, including regulatory submissions.

Required skills

• Formulation and process expertise for immediate‑release and extended‑release tablets and capsules (blending, dry/roller compaction, wet granulation, high‑shear, fluid‑bed, compression, coating, capsule filling).
• Knowledge of primary container‑closure components for oral solid dosage forms.
• Proficiency with statistical software such as Minitab or JMP.
• Use of problem‑solving tools (Ishikawa, Kepner‑Tregoe, 5‑whys).
• Experience with PAT tools (NIR, in‑line weight/force monitoring) and risk assessment methodologies.
• Strong understanding of GMP, ICH guidelines and regulatory expectations.