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.
Good understanding of drug development process, management of network of CRO’s, work in cross functional teams is an important asset for this function.
He or she is experienced in the preparation of drug substance development reports for the CM&C section of a number of IND/IMPD or NDA/MAA submissions.
The candidate has strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations.