MSAT Oral Solid Drug Product Expert CMVD Monotherapy

Servier Group; Suresnes; Sur place; EUR 120 000 - 160 000; Plein temps

Résumé du poste

Servier seeks a high‑caliber MSAT Oral Solid Drug Product Expert CMVD Monotherapy to lead technical stewardship across lifecycle, including tech transfers and regulatory support. You will partner with internal sites and external CMOs to ensure robust manufacturing, quality, and compliance for CMVD oral solid products.

The role requires deep formulation knowledge, hands-on experience with scale‑up and process verification, and strong cross‑functional leadership in a global matrix.

Qualifications

• Experience in CMVD or related oral solid dosage formulation and manufacturing support.
• Experience with regulatory submissions and GMP/ICH guidelines.
• Strong knowledge of blending, granulation, coating, compression and containment.
• Proven track record in tech transfers, deviations, and change controls.
• Excellent written and oral communication; able to work globally.
• Ability to lead cross-functional teams and manage multiple projects.

Responsabilités

• Act as the technical process owner for CMVD monotherapy products.
• Provide technical oversight of manufacturing processes at internal and external sites.
• Lead internal cross-functional Technical Teams; manage agendas and follow-up.
• Lead or support deviation investigations, root cause analyses, and CAPA definitions.
• Maintain CPV and process monitoring for assigned products across sites.
• Build and maintain MSAT knowledge repository for products and processes.
• Lead or support tech transfers, scale changes, PPQ, and launch readiness.
• Conduct process fit assessments, risk evaluations, and FMEA as part of lifecycle strategy.
• Support regulatory documentation and ensure GMP/ICH alignment.

Connaissances

GMP knowledge

Regulatory submissions

Cross-functional leadership

Project management

Statistical analysis (Minitab/JMP)

Tech transfers & CAPA

Quality systems understanding

Strong communication

Formation

Bachelor’s Degree in Pharmaceutical Sciences or Chemical Engineering

Master’s or PhD in Pharmaceutical Sciences or Chemical Engineering

Outils

Tablet presses

Capsule filling equipment

Fluid-bed coaters

Granulation equipment

Process validation tooling

Description du poste

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.

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.

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

• 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 content estimation) for real-time or near-real-time assurance of processes.
• Perform risk and criticality assessments to identify gaps and define improvements in line with quality, regulatory, and business expectations.
• Stay current with industry trends, scientific literature, and evolving technologies related to OSD manufacturing and MSAT best practices.

Education and Required Skills

• Minimum Bachelor’s Degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with minimum of 8-10 years relevant experience, or preferably a Masters or PhD in Pharmaceutical Sciences or Chemical Engineering or related technical field with a minimum of 5-8 years of relevant experience in drug product formulation and process development and manufacturing support including experience with regulatory submissions.
• In-depth knowledge of formulation concepts/techniques across immediate-release and extended-release oral solid dosage forms and relevant manufacturing processes, e.g., blending, granulation including dry/roller compaction and wet/high-shear/fluid bed technologies, tablet compression, tablet coating, capsule filling etc.
• In-depth knowledge of primary container closure components used for oral solid dosage forms.
• Expertise in use/application of basic statistical methodologies and softwares (e.g., Minitab, JMP or equivalent).
• Expertise in use/application of variety of problem‑solving tools such as Ishikawa, Kepner‑Tregoe (KT), five‑whys, etc.
• Experience leading or supporting tech transfers, deviation investigations, change controls, and regulatory documentation.
• Strong knowledge of GMP, ICH guidelines, and regulatory submission expectations for commercial products.
• Comfortable working in a global matrixed team with cross‑functional collaboration across Quality, Manufacturing, Supply Chain, and Regulatory.
• Strong ability to strategically plan, organize, and manage multiple projects simultaneously.
• Excellent written/oral communication and presentation skills.
• Excellent communication and documentation skills; able to interface effectively with internal stakeholders and external partners.
• A continuous improvement and learning mindset, aligned with Servier’s strategic direction and patient‑first values.

We are committed to equal opportunities and developing talents in all their diversity. We value both experience and the desire to engage daily in contributing to therapeutic progress for the benefit of patients. If this offer resonates with you, seize this opportunity to meet us!