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CMC (Chemistry, Manufacturing and Controls) Professional
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