Associate Director, Molecule Drug Substance MSAT

Position: Associate Director, Small Molecule Drug Substance MSAT
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 As part of Servier’s global MSAT (Manufacturing Science & Analytical Technology) organization, this role serves as a Subject Matter Expert (SME) in the manufacturing processes of commercial small molecule drug substances. The role reports to the Head of Small Molecules Drug Substances within MSAT.This position provides comprehensive technical support for assigned commercial small molecule drug substances manufactured at both internal Servier sites and external contract manufacturing organizations (CMOs).

The SME ensures process robustness, regulatory compliance, and performance monitoring through lifecycle management, tech transfers, production support, and continuous improvement efforts.

Primary Responsibilities Technical Oversight of Internal and External Manufacturing Processes Provide technical oversight of commercial small molecule drug substance processes, with particular attention to ADC linker and payload manufacturing, at Servier sites and CMOs through Virtual Plant Teams.

Critically assess process robustness and the control strategy: identify the parameters that drive reaction selectivity, impurity formation and purge, yield, crystallization, solid-state form, stability, and downstream conjugation performance.

Detect and manage emerging technical risks through CPV and trend analysis; challenge adverse trends, define escalation criteria, and recommend science- and risk-based actions before quality or supply is impacted.

Lead the technical contribution to deviations and recurring issues: structure root cause investigations, assess impact on linker or payload quality, define effective CAPAs, and confirm their effectiveness.

Ensure safe and compliant manufacture of highly potent payloads by contributing to containment, cleaning, cross-contamination prevention, handling, and EHS risk assessments in partnership with Quality, Manufacturing, and EHS.Capture and transfer process knowledge, including control-strategy rationale, process history, scale-up learning, and lessons from investigations and manufacturing campaigns.

Technology Transfer and Lifecycle Management Define the technical transfer strategy for linker and payload processes, ensuring that process knowledge, raw-material specifications and requirements, safe-handling practices are complete and understood by the receiving site.

Challenge receiving-site fit and readiness, including equipment capability, materials of construction, containment and cleaning, reaction-safety controls, mixing and heat transfer, filtration, drying, and the ability to control critical impurities and physical properties.

Identify and mitigate scale-up risks affecting reaction kinetics, addition and quench profiles, mass and heat transfer, work-up, chromatography where applicable, crystallization, hold times, stability, and batch reproducibility.

Lead process fit, risk assessment, and FMEA activities; translate identified risks into an actionable transfer plan with clear owners, acceptance criteria, and escalation paths.

Provide technical leadership for engineering and PPQ batches, rapidly assess unexpected results, determine comparability between sites, and ensure that critical gaps are closed before routine commercial manufacture.

Drive lifecycle improvements that measurably increase process robustness, impurity control, yield, throughput, containment, sustainability, and supply reliability without compromising product quality or regulatory commitments.

CMC and Regulatory Support Author or review CMC-related sections of regulatory submissions (e.g., post-approval changes,…