Scientific Fellow Analytical Development Trace Analysis at Vertex in Boston, MA

Save or bookmark jobs as you go and access them anytime later with your account.

Contacts

Description

Job Description:

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, structure elucidation, and familiarity with GLP/GMP principles experience preferred.

The Scientific Fellow I has an impressive history of accomplishments, which contribute significantly to the advancement of projects, and is recognized internally as a scientific leader and acknowledged throughout the company as expert. The Scientific Fellow I develops and applies novel solutions to significant project obstacles. In addition, the Scientific Fellow I demonstrates mastery of drug development processes and regulatory requirements by identifying needs and developing solutions in new areas. This role includes supervision and direction of laboratory staff and management of projects, including roles on cross-functional project teams representing Analytical Development.

Key Responsibilities:
  • 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.
  • Intellectual and technological leadership.
  • Contribute data, reports and strategy for regulatory submissions.
  • May supervise staff, ensuring the training and compliance of the team on appropriate regulations and SOPs.

Scientific and Communication Skills:
  • Recognized as an expert authority in structure elucidation, trace analysis and CMC regulatory practice and strategy.
  • Evaluates and introduces novel modes of scientific inquiry and technology to advance project goals and company objectives.
  • Communicates in written and spoken form with high precision and skill, to enable the effective dissemination, internally and externally, of advanced ideas.

Qualification:

  • Ph.D. with 10+ years relevant post-doctoral work experience or M.S. with 12+ years of relevant work experience or B.S. with 14+ years of relevant work experience.
  • The ability to work both independently and as part of an interactive team/matrix environment.
  • Established organizational skills.

Similar Jobs

See All »

Other Jobs at Vertex

See All »