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Senior Manager Manufacturing Programs

Amgen · Singapour

New
Senior 🇬🇧 English
MES contamination control electronic batch records

Job description

About the role

The Senior Manager Manufacturing Programs will own process responsibility for multiple biologic and synthetic products and lead the introduction of new products into Amgen's Singapore manufacturing facility. Reporting to the Director of Manufacturing Support, the role spans process ownership, contamination control, inspection readiness, MES, validation, and scheduling.

Key responsibilities

  • Lead new product/technology introductions and multi‑product campaigns in a compliant, agile, and cost‑effective manner.
  • Oversee cleaning validation and maintain the validated state of process equipment.
  • Ensure contamination control and inspection readiness across manufacturing operations.
  • Direct production interruption investigations and act as escalation point for process or equipment issues.
  • Manage deviations, change controls, CAPA, and corrective actions linked to products and equipment.
  • Implement and develop electronic batch records.
  • Drive continuous improvement initiatives and support site‑wide technical and non‑technical programs.

Required profile

  • Extensive experience in GMP manufacturing environments, preferably in biologics or synthetic products.
  • Proven leadership of cross‑functional teams and supervision of professionals handling new molecule introductions.
  • Strong decision‑making ability with minimal supervision and experience escalating operational issues.
  • Demonstrated track record of managing deviations, change controls, and corrective actions.

Required skills

  • Manufacturing Execution System (MES) expertise
  • Process validation knowledge
  • Contamination control practices
  • Electronic batch record management

Questions fréquentes

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Published 12 hours ago

Expires 1 month from now

3 views · 0 applications

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Amgen

Singapour