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