Senior Scientist, Analytical Chemistry

Vanda Pharmaceuticals Inc.; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Unlimited PTO

Parental leave

401k matching

Job summary

Vanda Pharmaceuticals Inc. is seeking an experienced analytical chemist in Washington, D.C. to lead the generation and review of analytical methods, stability protocols, and regulatory reports for APIs and impurities.

The role requires advanced degrees in analytical chemistry with substantial experience, strong familiarity with biologics and sterile products, and the ability to manage external CMOs while coordinating with cross-functional teams on INDs/NDAs.

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.

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.

Education

Masters (required)

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.

Equal Opportunity Employer

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 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.

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)