This message has been cross posted to the following eGroups: New Jersey Chapter and Statistical Consulting Section .
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The opening is to be filled soon. It is in NY/NJ area.
Responsibilities:
The person will provide statistical assessments and develop models for drug manufacturing process improvements, process monitoring, and process control purposes; the person will also actively be involved in troubleshooting and process validation activities, which includes adherence to regulatory and GMP requirements
- Support process validation and tech transfer activities by setting up DOE and perform statistical analysis of process validation data for proving validity and equivalence.
- Evaluate release and stability data to allow internal limit determination and identify sources of significant laboratory bias; evaluate impact of corrective and preventative actions to reduce or eliminate laboratory bias in test results.
- Review product assessment reports and to help determine the sampling and testing matrix for the justification and validation batches.
- Support analytical methods validation and method transfer by designing analytical robustness test and design required DOE and statistical assessment to ensure method robustness and effectiveness during the validation and transfer
- Support new process improvement by determining the new process capabilities and stability.
- Develop statistical training modules and give training to the technical staff
Experiences:
· MSc. in Statistics, natural science or Chemical Engineering background a plus, at least 7 years of experience as statistician in pharmaceutical processing or analytical testing
· Deep statistical and mathematical understanding in the field of DoEs and multivariate statistics
· Experience in the packaging technology for pharmaceutical products preferred
· Fundamental understanding of standard pharmaceutical analytical testing
· Strong expertise in tech transfer
· Experience in the following software: Minitab, JMP, SAS
· Experience in lean, six sigma, DOE
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Jie Sheng
Novartis Pharmaceuticals Corporation
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