LocationLocation: Ireland, Poland or FranceTherapeutic AreaTherapeutic Area: Cardio Metabolism & Venous Diseases (CMVD)ExpertiseExpertise: Single-Pill Combinations (SPC) / Fixed-Dose Combinations (FDC)Role OverviewReporting to the Global Head of MSAT Oral Solid Drug Products, you will serve as the global technical authority for our CMVD Single‑Pill Combination (SPC) portfolio. You will lead a team of Subject Matter Experts (SMEs) to ensure the seamless commercialization, scale‑up, and lifecycle management of complex OSD products, including bilayer tablets, pellets‑in‑capsules, and mini‑tablets.Key ResponsibilitiesTechnical Authority: Lead the manufacturing process knowledge for commercial OSD products, overseeing technology transfers, validation, and lifecycle management across internal and external sites.Scientific Rigor: Champion advanced process science frameworks, including Quality by Design (QbD) and Process Analytical Technology (PAT).Process Robustness: Implement Continued Process Verification (CPV) through risk‑based monitoring of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).Regulatory Strategy: Provide strategic technical input for CMC sections of regulatory submissions and interact with global Health Authorities (EMA, FDA, PMDA).Strategic Leadership: Collaborate with CMC counterparts to ensure effective technical transitions from development to commercial manufacturing.Your ProfileEducation: Advanced degree (PhD preferred, or MSc) in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering.Experience: 15+ years in OSD process development and manufacturing sciences.Technical Expertise: Deep understanding of unit operations related to SPCs (wet/dry granulation, roller compaction, multi‑layer compression, coating, and capsule filling for pellets/mini‑tablets).Leadership: Proven track record of coaching technical teams and navigating global matrix organizations.Mindset: A growth‑oriented leader passionate about building capabilities and driving continuous improvement in a transforming industrial environment.Why Join SERVIER?By joining SERVIER, you become part of an independent group governed by a non‑profit foundation. This unique structure allows us to focus on long‑term therapeutic progress and reinvest 20% of our non‑generics turnover into R&D.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.
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