Technical Support Release and Stability Lab at Vertex in Boston, MA

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Description

Job Description:

This role provides technical support for Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.


Key Responsibilities:
  • Assist in overseeing of RSL method validations and/or method transfer activities to support project timelines.
  • Serve as RSL representative in cross-functional, cross-departmental working teams
  • May execute method validations and/or transfers as needed
  • Support in the managing of RSL change controls, deviations, and investigations.
  • Authors laboratory OOS/OOT investigations and deviations. Helps identify corrective actions to prevent reoccurrence
  • Assist in troubleshooting of analytical methods when necessary
  • Authors and reviews data, SOPs, analytical methods, protocols and reports
  • Participates in compliance related teams working towards the goal of continuous improvement.
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Qualification:

  • A minimum of a Bachelor Degree in science or related discipline is required.
  • 4+ years of experience in pharmaceutical/biopharmaceutical industry with at least 1 year of method validation/transfer experience.
  • Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
  • Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
  • Strong attention to detail
  • Effective communication skills, both verbal and written.

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