Principal Scientist, Analytical Development

A company is looking for a Principal Scientist, Analytical Development. Key Responsibilities Design, review, and approve analytical methods and documentation for drug substances and drug products Author and review regulatory submission sections related to analytical methods Oversee batch release activities and ensure compliance with GMPs and regulatory standards Required Qualifications PhD in Chemistry, Analytical Chemistry, or related field with 8+ years of relevant experience Expertise in analytical method development, validation, and regulatory submissions Strong knowledge of GMPs, ICH guidelines, and stability study protocols Proficiency in SharePoint for document management Experience with SPE methods and placebo fingerprinting analysis

Apr 7, 2025 - 21:27
 0
Principal Scientist, Analytical Development
A company is looking for a Principal Scientist, Analytical Development. Key Responsibilities Design, review, and approve analytical methods and documentation for drug substances and drug products Author and review regulatory submission sections related to analytical methods Oversee batch release activities and ensure compliance with GMPs and regulatory standards Required Qualifications PhD in Chemistry, Analytical Chemistry, or related field with 8+ years of relevant experience Expertise in analytical method development, validation, and regulatory submissions Strong knowledge of GMPs, ICH guidelines, and stability study protocols Proficiency in SharePoint for document management Experience with SPE methods and placebo fingerprinting analysis