MSAT Oral Solid Drug Product Expert CMVD Monotherapy

Date de parution: 15 sept. 2026

Ville: SURESNES

Pays/RÉgion: FR

Type de contrat: CDI

NÉ offre: 10664

MSAT Oral Solid Drug Product Expert CMVD Monotherapy

We are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to therapeutic progress for the benefit of patients."

In R&D, we also focus on creating new medicines that slow down or halt the progression of rare neurological disorders and significantly improve patient quality of life.

Who are we? 22,000 passionate individuals from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, motivated by the desire to care, to dare, to grow, and to commit to being useful to those in need.

Come and experience and contribute to our commitment #MovedByYou.

www.servier.com

Within Servier Industry, the Manufacturing Science and Analytical Technology (MSAT) organization plays a key role in driving technical excellence, industrial transformation, and lifecycle management — enabling manufacturing robustness, quality, and compliance across all product modalities and technologies.

Location: Suresnes (Paris), Bolbec (Rouen / Le Havre) or Gidy (Orleans).

Role Summary

Within MSAT, the Oral Solid Drug Product team is responsible for providing technical stewardship and manufacturing science support across oral solid drug product lifecycle. The Oral Solid Drug Product Expert serves as the technical subject matter expert for CMVD monotherapies reporting to MSAT Oral Solid Drug Product CMVD (Cardio Metabo Venous Diseases) Monotherapy Lead. This role provides scientific and process expertise to support the manufacturing and lifecycle management of CMVD oral solid drug products across internal and external manufacturing sites.

Primary Responsibilities

Technical Oversight of Internal and External Manufacturing Processes

• Act as the technical process owner for CMVD monotherapy products within MSAT scope at internal and external manufacturing sites.
• Provide technical oversight of manufacturing processes for assigned oral solid commercial products at Servier internal sites in collaboration with Site MSAT and at external partners (CMOs) as part of Virtual Plant Teams
• Lead internal cross-functional Technical Teams to facilitate drug product related technical topics in collaboration with other functions
• Prepare and manage meeting agendas, minutes, and action follow-up
• Facilitate alignment on technical project timelines, supply impact, and budget considerations.
• Lead or support deviation investigations, root cause analyses, and CAPA definition for process related issues, ensuring robust closure and knowledge transfer.
• Maintain and oversee process monitoring and Continued Process Verification (CPV) for assigned commercial products across manufacturing sites.
• Build and maintain MSAT knowledge repository for assigned commercial products and processes

Technology Transfer and Lifecycle Management

• Lead or support tech transfers, scale changes, PPQ, and launch readiness activities across global sites.
• Conduct and document process fit assessments, risk evaluations, and FMEA as part of the lifecycle management strategy.
• Participate in process optimization efforts, including yield, throughput, and quality performance improvements across the network.

CMC and Regulatory Support

• Author or review CMC-related sections of regulatory submissions (e.g., post-approval changes, variations, new market filings as needed).
• Support Regulatory CMC in responding to health authority questions related to commercial manufacturing processes and controls.
• Ensure manufacturing and validation strategies are aligned with GMP, ICH, and global regulatory expectations.

Subject Matter Expertise and Continuous Improvement

• Support implementation and optimization of manufacturing processes and related control/sampling strategies (e.g., granulations, compression, coating, pellet layering, capsule filling, segregation control measures).
• Specify and support qualification/optimization of tooling and equipment such as: tablet presses, precision capsule fillers for pellets, fluid-bed coaters, high-shear granulators, roller compactors, and containment/segregation equipment.
• Anticipate scale-dependent challenges (e.g., compression dwell time effects, layer adhesion, segregation during handling) and define scale-up acceptance criteria, equivalence studies and narrative for regulatory dossiers.
• Recommend and deploy PAT tools where beneficial (NIR, weight/force monitoring, in-line conte