Scientist II, Analytical Development – Trace Analysis

This role supports drug development programs at Vertex through analytical methods development, execution and validation, with an emphasis on trace analysis. Expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, especially LCMS, GCMS, HPLC, prep HPLC and analytical SFC. Predominantly small molecule analyses but experience with large molecule and protein characterization is also desired. Trace analysis, bioanalytical and familiarity with GLP/GMP principles experience preferred.
Key Responsibilities include but are not limited to:
• Identify, isolate and quantify impurities at trace levels by LCMS or GCMS.
• Develop analytical methods to characterize critical quality attributes of drug substances and drug products, e.g assay and impurities profiles.
• Execute methods and document results to support chemical development, formulation development, stability studies, and regulatory filings.
• Design and perform sample analysis for process development and QbD characterization of analytical methods.
• Evaluate a wide variety of established and new analytical approaches to characterization of pharmaceutical compounds, formulations and excipients.
Preferred Education and Experience:
• Ph.D. with 2-5 years relevant post-doctoral work experience or M.S. with 5+ years of relevant work experience or B.S. with 8+ years of relevant work experience.
• The ability to work both independently and as part of an interactive team/matrix environment.
• Excellent written and verbal communication skills.
• Established organizational skills.