Process Chemist Role
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* We are seeking a skilled Process Chemist to develop and maintain expertise in CMC regulatory topics.
* This strategic role involves developing CMC strategies for global regulators and supporting submissions pertinent to CMC.
* The successful candidate will review data and reports for accuracy and consistency with regulator's expectations.
* As a key member of our team, you will collaborate with stakeholders to identify contract manufacturers and provide CMC expertise.
* You will lead or participate in engineering projects as subject matter expert within the field of CMC and test method development.
Requirements
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* Bachelor's degree in engineering/science or a related field is required.
* A minimum of 3 years' experience with CMC, strong knowledge of ISO13485/FDA practices and GMP, GLP or similar regulated industry standards is essential.
Key Skills
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* CMC strategy and planning
* Certificate validation and audit preparation
* Supply chain management
* Risk assessment and mitigation
* Regulatory affairs