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MSAT Oral Solid Drug Products CMVD SPCs Expert

Servier Ireland · Arklow

🇬🇧 English
Oral solid dosage manufacturing Multi-API formulation Technical transfer Scale-up

Job description

About the role

Servier is seeking a Global MSAT Oral Solid Drug Products CMVD SPCs Expert to lead scientific support and technical stewardship for its Cardio‑Metabolism & Venous Disease portfolio. The role bridges pharmaceutical science and industrial performance, ensuring complex multi‑API products are manufactured to the highest standards.

Key responsibilities

  • Act as the global SME for Single‑Pill Combination (SPC) manufacturing across Servier sites and external CMOs.
  • Maintain the MSAT knowledge repository and oversee Continued Process Verification (CPV) by monitoring Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
  • Lead technical transfers, scale‑up activities, and Process Performance Qualification (PPQ) projects.
  • Conduct deep‑dive risk assessments (FMEA) and evaluate process fit for new formulations.
  • Lead complex deviation investigations and root‑cause analyses.

Required profile

  • Extensive experience in oral solid dosage manufacturing, particularly multi‑API and SPC products.
  • Proven ability to work with internal sites and virtual plant teams (CMOs).
  • Strong analytical mindset with a track record of ensuring process robustness and compliance.

Required skills

  • Oral solid dosage manufacturing
  • Multi‑API formulation
  • Process validation and CPV
  • Risk assessment (FMEA)
  • Technical transfer and scale‑up

Questions fréquentes

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Published 3 months ago

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Servier Ireland

Arklow