k****n
发帖数: 98 | 1 Please contact through mitbbs
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A full – time statistical consultant position in a major Pharmaceutical
company manufacturing site
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 | k****n
发帖数: 98 | 2 Contact through Mitbbs if interested.
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drug
control
【在 k****n 的大作中提到】
: Please contact through mitbbs
: ============================================================================
: =================
: A full – time statistical consultant position in a major Pharmaceutical
: company manufacturing site
: 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
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