Assoc Director, Oral Solid Drug Product

Type of

Contract:

Full-time Employment / Unlimited

About Servier

With commercial stage products and a promising pipeline, we are Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, cardiology, and other therapeutic areas.

Servier’s 2030 Ambition aims to establish the Group as a recognized, innovative, and patient-centered leader in Oncology, Neurology, and Cardiometabolism & Venous Diseases (CMVD). Over half of our research and development efforts are focused on targeted therapies to address unmet patient needs.

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 Associate Director, Oral Solid Drug Product serves as the technical subject matter expert for Onco/Neuro Oral Solid products reporting to the MSAT Oral Solid Drug Product Onco/Neuro Lead. This role provides scientific and process expertise to support the manufacturing and lifecycle management of Oncology and Neurology related oral solid drug products across internal and external manufacturing sites.

Primary Responsibilities

Technical Oversight of Internal and External Manufacturing Processes

• 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,…