Senior Scientist, Analytical Chemistry

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

Job 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.

Job 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 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

Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.

This is a full-time, onsite position requiring five days per week in the office.

If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.

Education

Masters (required)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.