MSAT Oral Solid Drug Products CMVD SPCs Expert

MSAT Oral Solid Drug Products CMVD SPCs Expert

Servier

Multiple Locations

Are you a technical authority in complex Oral Solid Dosage manufacturing? Do you excel at bridging the gap between pharmaceutical science and industrial performance?

We are looking for a Global MSAT Oral Solids Drug Products CMVD SPCs Expert to provide high-level scientific support and technical stewardship for our Cardio Metabolism & Venous Diseases (CMVD) portfolio.

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.