Senior Scientist, Analytical Chemistry

Role Summary

Senior Scientist, Analytical Chemistry

Responsibilities

• Generation and/or review of analytical methods and stability study protocols and reports
• Troubleshooting issues related to analytical methods/data
• Management of analytical chemistry activities at third-party CMOs
• Management of synthesis and characterization of reference standards for APIs and impurities
• Preparation of analytical chemistry and stability related CMC sections of INDs, IMPDs and NDAs
• Trending of stability data for shelf-life prediction, Analytical comparability protocol and execution
• Design and development of new assays, including peptide mapping and other advanced analytical methods.
• Separation and characterization of protein drug candidates.
• Ensuring all analytical activities are conducted in compliance with cGMP, safety, and regulatory requirements.

Qualifications

• Ph.D. in analytical chemistry with 2-4 years of experience or M.S. in analytical chemistry with 7- 10 years of experience
• Thorough knowledge and understanding of analytical chemistry methodologies commonly used for characterization of small molecule drug substances and drug products
• Thorough knowledge and understanding of biologics and sterile products is mandatory
• Familiarity with ICH, FDA, and USP guidance documents relating to drug substance and product analysis and quality control
• Excellent written and oral communication skills
• Ability to work independently on projects
• Ability to work effectively and efficiently on multiple projects

Skills

• Analytical method development and validation
• Stability testing and data trending
• CMC documentation for regulatory submissions
• Project management and cross-functional collaboration