Associate Director – Manufacturing Electronic Batch Record (mebr)
AstraZeneca
Singapore
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Electronic batch record (ebr) creation and management
Gmp manufacturing experience in large matrix organization
Mes system ownership and ebr review processes
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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.
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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
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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.
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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