Senior Scientist, Analytical Chemistry

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 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.