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Process Development Specialist
2 weeks ago
This strategic role involves maintaining high-level expertise in FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
Key Responsibilities:- Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
- Ensure data and reports are technically reviewed for accuracy and consistency with regulator's expectations.
- Collaborate with stakeholders to identify contract manufacturers and API vendors, as well as provide technical guidance on qualification and audit processes.
- Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
- Bachelor's degree, Master's, or PhD is required, preferably in engineering/science or a related field.
- Minimum of 3 years' relevant experience with CMC.
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP, or similar regulated industry standards.
- Familiarity with FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH CMC regulatory topics.
