Current Opportunities

Senior Pharmaceutical Chemist

Job Description:

  1. Preparation, review and QC checks of drug substance and drug product CMC sections of INDs, NDA, IMPDs and MAAs
  2. Ensure Quality Assurance/GMP compliance at contract manufacturing companies involved in manufacturing/packaging commercial products and clinical trial batches
  3. Investigation of product complaints related to commercial products
  4. Participate in team meetings and prepare project status updates

Roles and Responsibilities:

  1. Preparation, review and QC checks of CMC sections of INDs, NDAs, IMPDs and MAAs
  2. Investigation of product complaints and preparation of investigation reports
  3. Preparation and maintenance of Vanda’s SOPs for CMC activities
  4. Perform GLP audits of bioanalytical testing laboratories/prepare audit reports
  5. Perform GMP audits of manufacturing, packaging and labeling sites/prepare audit reports

Position Requirements

Successful candidates will have the following background/experience:

  1. BS or MS degree in chemistry
  2. 5 years of experience in preparation of CMC documents and performing GMP audits
  3. Knowledge ICH/CTD/FDA/EMA guidelines on preparation of CMC documentation
  4. Knowledge of ICH Q7 and 21 CFR Parts, 11, 58, 210 & 211 and EudraLex GMP regulations
  5. Excellent written and oral communication skills
  6. Ability to work effectively and efficiently on multiple projects

Vanda Pharmaceuticals offers a competitive compensation package with excellent benefits and a 401(k) matching program. Vanda is an equal opportunity employer, committed to the hiring, advancement and fair treatment of individuals without regard to race, color, religion, sex, sexual preference, age, national origin, ethnicity, disability, or any other protected status designated by law.

Applicants should submit a cover letter with their Curriculum Vitae or Resume together with the names, addresses and telephone numbers of 3 references to:

Human Resources
Reference #: M7009
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Avenue NW, Suite 300E
Washington, DC 20037

"Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility."

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