MSAT Oral Solid Drug Products CMVD SPCs Lead

MSAT Oral Solid Drug Products CMVD SPCs Lead

Servier

Poland, Ireland or France

The Role:

Reporting 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 Responsibilities:

• Technical 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 Profile:

• Education: 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.