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 k 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.
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 between 8 : 00 AM and 5 : 30 PM ET, Monday through Friday.
Senior Scientist, Analytical Chemistry • Washington, District of Columbia, US
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