Hilleman Laboratories Singapore Pte. Ltd. is seeking a Senior Biotechnologist to oversee the technical transfer of processes and products from R&D to GMP clinical manufacturing. The ideal candidate will have a relevant educational background and experience in biologics or vaccine manufacturing, with a strong emphasis on compliance and collaboration
Job Summary
The role acts as a user representative to oversee the technical transfer of process and product from R&D to GMP clinical manufacturing.
Candidates must execute manufacturing activities safely while ensuring all data is recorded in an ALCOA manner within Manufacturing Batch Records.
The position requires leading root cause analysis for operational deviations and serving as a subject matter expert during regulatory audits.
Matching Summary
Match Score: 85
Hilleman Laboratories Singapore Pte. Ltd. is seeking a Senior Biotechnologist to oversee the technical transfer of processes and products from R&D to GMP clinical manufacturing. The ideal candidate will have a relevant educational background and experience in biologics or vaccine manufacturing, with a strong emphasis on compliance and collaboration.
Skills & Requirements
Must-have
Bachelor's degree in engineering or life science
2-6 years relevant industry experience
cGMP practices for fill finish processes
Good Documentation Practices (GDP)
Manufacturing Batch Records (MBRs) recording
Root cause analysis for operational deviations
Nice-to-have
Experience with problem solving and statistical tools
Plant start up or commissioning experience
Total Productive Maintenance participation
Front line troubleshooting of Fill finish equipment
Positive influencing abilities and drive
Key Requirements
Bachelor's degree in Bio/chemical engineering/life science/biology/chemistry
2-6 years relevant industry experience
Knowledge of cGMP practices applicable to fill finish processes
Experience in biologics and/or vaccines manufacturing