Posted Date: Jan 15 2020
- Evaluate and implement (including design, install, commission and validate) selected Process Analytical Technology (PAT) application(s) on drug substance manufacturing processes.
- Lead and mentor less experienced PAT chemist(s)/engineer(s) Perform life cycle maintenance on models associated with medium-high impact PAT applications
- Provide leadership to identify, evaluate, select, design, commission,and validate suitable and value add PAT applications in drug substance manufacturing processes to enhance process understanding, to effect quality control and to support process optimization and troubleshooting.
- Classify PAT applications according to their respective criticality (low, medium, high) based on the info and data generated by these applications in making GxP decisions
- Proactively contribute to PAT and chemometric community of practice (CoP) activities, share lessons learnt with other members of the CoP, Mentor and coach less experienced members of the PAT-chemometric sub team
- Ensure that PAT application implementations are in full compliance with cGMP, EHS and other regulatory requirements
- Bachelor of Chemical Engineering/Chemistry (Masters or suitable equivalent preferred for
- senior/principal grade)
- 2-3 years of relevant experience in the chemical industry (min. 5 years for senior, and min 7 years for principal grade)
- Good working knowledge of GMP
- Proven track record in implementing PAT applications
- Good instrument/process troubleshooting / optimization skills
- Awareness of statistics
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