CMC position

We are always seeking new consultants to expand our team which includes seasoned consultants and new professionals considering consulting for the first time.
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CMC (Chemistry, Manufacturing and Controls) Professional

General overview:

  • Oversee the development and implementation of manufacturing strategies clients’ investigational drugs including the validation of API and Drug Product manufacturing processes
  • Participate in the preparation of client Regulatory submission documents relating to a client's development activities and product approvals; prepares and reviews relevant CMC sections of regulatory dossiers
  • Define, implement and manage process development and validation for API and formulations at third party contract service providers.
  • Ensures manufacturing milestones are met to support regulatory approval for client product development projects.
  • Advises with the development of the manufacturing strategy and assessment of risks associated with API and Drug Product manufacturing
  • Ensures that proper statistical methods are applied to testing, validation, sampling, and inspection
  • Plans and implements technical studies documenting development that are suitable for reference or inclusion in regulatory documentation
  • Resolves outstanding quality issues, deviations and CAPAs related to CMC activities
  • Prepares and reviews relevant CMC sections of regulatory dossiers
  • Participates in relevant meetings/teleconferences with team and with clients 

Or, know someone who would be a perfect fit? Let them know!

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