Drug Substance Development (Sr) Lead Mechelen Belgium,
As Lead drug substance development CMC, you will be responsible for the drug substance (API) development and up-scaling strategy and execution thereof for various development projects.
- API synthesis route development and solid state development
- Upscaling, manufacturing of non-GMP and GMP batches
- Evaluation of stability data and impurity identification/synthesis
- Evaluation of physico-chemical data of lab scale/pilot scale batches and adjustment of processes as needed
- Knowledge of potential mutagenic impurity assessment
- Preparation of drug substance development/manufacturing source documents related to clinical trial applications and prepare responses to drug substance related regulatory questions
- Selection and management of contractors executing the drug substance development/manufacturing activities
- Collaboration with Quality and Compliance department to assure that CROs are performing according to cGMPs
- Interaction with analytical and drug product CMC team members to build the CMC development plan and ensure execution thereof
The successful candidate has a PhD in organic chemistry and at least 5 years of experience in drug development, especially in drug substance development/upscaling area.
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