Senior Scientist, Analytical Chemistry

Responsibilities:
- Generate and/or review analytical methods and stability study protocols and reports.
- Troubleshoot issues related to analytical methods/data.
- Manage analytical chemistry activities at third-party CMOs.
- Manage synthesis and characterization of reference standards for APIs and impurities.
- Prepare analytical chemistry and stability-related CMC sections of INDs, IMPDs, and NDAs.
- Trend stability data for shelf-life prediction; develop and execute analytical comparability protocols.
- Design and develop new assays, including peptide mapping and other advanced analytical methods.
- Separate and characterize protein drug candidates.
- Ensure analytical activities are conducted in compliance with cGMP, safety, and regulatory requirements.

Qualifications/Requirements:
- 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 of analytical chemistry methodologies for characterization of small-molecule drug substances and drug products.
- Thorough knowledge of biologics and sterile products (mandatory).
- Familiarity with ICH, FDA, and USP guidance documents for drug substance/product analysis and quality control.
- Excellent written and oral communication skills.
- Ability to work independently and manage multiple projects.

Benefits (as stated): incentive compensation; health insurance; unlimited paid time off; parental leave; 401k matching; other benefits.

Application instructions: Contact 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday–Friday, for assistance (state/local pay transparency details).