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
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