Analytical SME & CMC Writer

Job Summary

To support external drug substance and drug product development programs, the contract position for an Analytical SME & CMC Writer will work remotely while providing scientific leadership in analytical development and managing documentation for regulatory submissions, requiring availability during east coast hours.

Key Responsibilities

• Provide scientific leadership in external drug substance/drug product analytical development and quality control, including method development and validation
• Manage documentation workflow in Veeva RIM system and author CTD Module 3 documents, particularly those related to analytics
• Contribute to the development of stability programs and specifications in collaboration with internal and external teams

Required Qualifications

• Over 6 years of experience in pharmaceutical/biotech CMC and analytical development
• Demonstrated experience with regulatory submissions and familiarity with GMP and regulatory guidelines
• Advanced degree (PhD preferred) or Master's and Bachelor's in Analytical Chemistry, Pharmaceutical Sciences, or a related field