Role SummaryAs 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 ResponsibilitiesTechnical 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, 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.
Continuous Improvement- Stay current with industry trends, scientific literature, and evolving technologies related to manufacturing and MSAT best practices.
- Promote Servier's 2030 Ambition by supporting digital, sustainable, and patient-centered innovation in technical operations.
Education and Required Skills- Bachelor's degree with 10 years of experience, Master's degree with 8 years of experience or PhD with 5 years of experience in Organic/Medicinal Chemistry, with demonstrated proficiency in synthetic chemical process development and manufacturing support for small molecule drug substances, linker-payloads, and HPAPIs.
- Experience in lifecycle management across late-stage clinical and commercial programs forLinker-Payload chemistry and the technical requirements for subsequent bioconjugation is a plus.
- In-depth knowledge of complex multi-step organic synthesis, including experience with highly potent compounds and specific isolation/purification technologies (e.g., preparative HPLC).
- Expertise in the use and application of basic statistical methodologies and software (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 in a GMP environment.
- Strong knowledge of GMP, ICH, and EHS guidelines for HPAPI handling (containment levels, OEL).
- Comfortable working in a global matrixed team with cross-functional collaboration across Quality, Manufacturing, Supply Chain, and Regulatory.
- Strong ability to organize, and manage multiple products simultaneously
- Excellent English communication and documentation skills; able to interface effectively with internal stakeholders and external partners in an international environment.
- A continuous improvement and learning mindset, aligned with Servier's strategic direction and patient-first values.
Travel and Location- Domestic and international travel up to 20%
- The position is a full-time remote role and will preferably be based on the East Coast of the United States.
Job DescriptionCandidate Profile 
