Senior Analytical Chemist - Method Development & Stability

Vanda Pharmaceuticals Inc.; Washington (District of Columbia); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401k matching program

Unlimited paid time off

Parental leave

Job summary

Vanda Pharmaceuticals Inc. in Washington, DC is seeking a senior-level analytical chemist to lead method development, validation, and stability reporting for small molecules and biologics.

The role emphasizes cGMP compliance, cross-functional collaboration, and regulatory readiness for INDs/NDAs. The candidate will oversee third-party CMOs, drive method development for complex assays, and contribute to stability studies and regulatory sections.

Qualifications

• PhD in analytical chemistry with 2–4 years of experience or MS with 7–10 years.
• Knowledge of analytical chemistry methods for small molecules and biologics.
• Experience with ICH/FDA/USP guidelines for drug substances and products.

Responsibilities

• Generate or review analytical methods and stability study protocols and reports.
• Troubleshoot analytical methods/data issues.
• Manage analytical chemistry activities at third-party CMOs.
• Oversee synthesis and characterization of reference standards for APIs and impurities.
• Prepare analytical chemistry and stability sections of INDs, IMPDs and NDAs.
• Trend stability data for shelf-life prediction and comparability protocols.
• Design new assays (peptide mapping and advanced methods).
• Characterize protein drug candidates.

Skills

Analytical chemistry knowledge

Regulatory familiarity

Written & verbal communication

Independent work

multitask management

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

Job description

Vanda Pharmaceuticals Inc. in Washington, DC is seeking a senior-level analytical chemist to lead method development, validation, and stability reporting for small molecules and biologics.

The role emphasizes cGMP compliance, cross-functional collaboration, and regulatory readiness for INDs/NDAs. The candidate will oversee third-party CMOs, drive method development for complex assays, and contribute to stability studies and regulatory sections.