MSAT Oral Solid Drug Products CMVD SPCs Expert (Poland, Ireland or France)

MSAT Oral Solid Drug Products CMVD SPCs Expert (Poland, Ireland or France)

Our independent pharmaceutical group governed by a Foundation.

Location: Poland, Ireland or France

Department: Global Manufacturing Science and Analytical Technology (MSAT)

Focus: Single-Pill Combinations (SPC) / Multi-API Formulations – Therapeutic Area: Cardio-Metabolism & Venous Disease (CMVD)

The Role

Reporting to the Global MSAT Oral Solids Drug Products CMVD SPCs Lead, you will act as the Technical Subject Matter Expert (SME) for Single-Pill Combinations (SPCs). You will be responsible for the technical oversight of manufacturing processes across internal sites and external partners (CMOs), ensuring that complex multi-API products—such as bilayer tablets, pellets-in-capsules, and mini-tablets—are manufactured to the highest scientific standards.

Key Responsibilities

• Technical Process Ownership: Serve as the global SME for SPC manufacturing, providing oversight for both internal Servier sites and Virtual Plant Teams (CMOs).
• Process Robustness & CPV: Maintain the MSAT knowledge repository and oversee Continued Process Verification (CPV) by monitoring Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Lifecycle Management: Lead technical transfers, scale-up activities, and Process Performance Qualification (PPQ). Conduct deep‑dive risk assessments (FMEA) and process fit evaluations.
• Scientific Problem Solving: Lead complex deviation investigations and root cause analyses (using tools like Ishikawa or Kepner‑Tregoe) to ensure robust CAPA implementation.
• Regulatory & CMC Excellence: Author and review CMC sections for regulatory submissions and variations, ensuring alignment with GMP, ICH, and global health authority expectations.
• Innovation: Deploy Process Analytical Technology (PAT) tools (NIR, in-line monitoring) and optimize manufacturing sequences for multi-layer and multi-component dosage forms.

Your Profile

• Education: MSc or PhD in Pharmaceutical Sciences, Chemical Engineering, or a related field (or a Bachelor’s with significant equivalent experience).
• Experience: 5–10 years of expertise in OSD formulation, process development and manufacturing support, with a proven track record in regulatory submissions.
• Technical Mastery: Deep scientific understanding of unit operations for SPCs: wet/dry granulation, roller compaction, multi‑layer compression, and specialized capsule filling.
• Analytical Skills: Proficiency in statistical methodologies and software (Minitab, JMP) for process data analysis.
• Mindset: A collaborative professional comfortable in a global matrix environment, driven by continuous improvement and a patient‑first philosophy.

Why Join SERVIER?

Joining SERVIER means contributing to an independent group governed by a non‑profit foundation. We reinvest 20% of our non‑generics turnover into R&D, allowing us to focus on long‑term innovation and sustainable medical solutions.

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.