We are seeking an experienced Drug Substance Scientist / Manager (CMC ā API) to support our client in the development, scaleāup, and GMP manufacturing of a new smallāmolecule drug substance in close collaboration with external CDMOs. This is a purely industryāfocused role ā applied, processāoriented, and directly linked to manufacturing readiness. It is not a basic research or academic laboratory position.
You will work at the interface of development, manufacturing, and quality to ensure robust API processes and a compliant drugāsubstance supply for preclinical and clinical stages.
Key Responsibilities
- Contribute to Quality by Design (QbD) activities including CQA assessments, process FMEA, parameter criticality, and comparability assessments.
- Evaluate CDMO development proposals, manufacturing data, deviations, and campaign performance.
- Support GMPācompliant API production, including review of batch records, investigations, and change controls.
- Coordinate CDMO interactions and contribute to defining and tracking technical and operational KPIs.
- Prepare clear reports and presentations; communicate results effectively to internal project teams.
- Support setting of API specifications and contribute to SOP updates related to QbD and process development.
- Identify digitalization needs and support implementation efforts within the CMC team.
- Develop internal training materials related to QbD concepts and processādevelopment tools.