MSAT Oral Solid Drug Product Expert CMVD Monotherapy

Servier

Suresnes, France

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:
- o Prepare and manage meeting agendas, minutes, and action follow-up.
- o 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 extendedrelease 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 e.g. 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.