Associate Director – Manufacturing Electronic Batch Record (mebr)

AstraZeneca

Singapore
**
Electronic batch record (ebr) creation and management
Gmp manufacturing experience in large matrix organization
Mes system ownership and ebr review processes
** AstraZeneca is seeking an Associate Director for Manufacturing Electronic Batch Record (MEBR) at their new biologics manufacturing campus in Singapore. The role involves establishing and managing EBR capabilities to ensure compliance and efficiency in batch record execution within a dynamic, innovative environment focused on sustainability and advanced digital technology. **

Job Summary

  • This role is accountable for establishing and leading the Electronic Batch Record capability at AstraZeneca's new USD 1.5 billion biologics manufacturing campus in Singapore.
  • The position requires deep expertise in translating manufacturing processes into executable electronic batch records that enable efficient batch execution and accelerated release.
  • Candidates must demonstrate a proven track record of transitioning from project start-up into routine GMP manufacturing while maintaining high regulatory standards.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an Associate Director for Manufacturing Electronic Batch Record (MEBR) at their new biologics manufacturing campus in Singapore. The role involves establishing and managing EBR capabilities to ensure compliance and efficiency in batch record execution within a dynamic, innovative environment focused on sustainability and advanced digital technology. **

Skills & Requirements

Must-have

  • Electronic Batch Record (EBR) creation and management
  • GMP manufacturing experience in large matrix organization
  • MES system ownership and EBR review processes
  • Data integrity compliance with ALCOA+ standards
  • Transitioning from project startup to commercial operations

Nice-to-have

  • Lean Six Sigma certification or Green Belt
  • Experience defending FDA/EMA inspections
  • Advanced skills in PAS-X platform workflows
  • Leading adoption and training across global sites
  • Using EBR data for continuous process verification

Key Requirements

  • Degree in Engineering or Pharmaceutical Sciences
  • Strong experience in GMP manufacturing industry
  • Proven experience in batch record creation and review
  • Deep understanding of shopfloor operations
  • Leadership experience in project to commercial transition

Work Rights

Not specified

Tailored Resume

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