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 CMOsManagement of synthesis and characterization of reference standards for APIs and impurities
- Preparation of analytical chemistry and stability related CMC sections of INDs, IMPDs and NDAsTrending 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.
Qualifications: EDUCATIONMasters or better
Job Summary
Requisition Number: SENIO002384Job Category: General
Schedule: Full-Time
