- The core purpose of the job is to manage the analytical development for various development projects.
- As Lead analytical development CMC, you will be responsible for the analytical development strategy for drug substance and drug product and execution thereof for various development projects.
- Analytical method development and validation for drug substance and drug product analysis (non GMP and GMP)
- Stability studies and shelf life determination of drug substance and drug product (development and ICH studies), evaluation and characterization of impurities
- Specification development for drug substance and drug product
- preparation of analytical CMC source documents for clinical trial applications (quality section) and prepare responses to regulatory questions
- Selection and management of contractors executing the analytical development activities
- Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs
- Interaction with other CMC team members (CMC Lead, Drug Substance Lead and Drug Product Lead) to build the CMC development plan and ensure execution thereof
- The analytical development lead shall decide on the CRO performing the analytical development activities and define the analytical development strategy.
- You have a Master degree-, or PhD in analytical chemistry, or pharmaceutical sciences, or Bio-engineering, or equivalent by experience .
- You have a minimum of 5 year experience in drug development, especially in analytical development and are experienced in the preparation of analytical development reports for a number of IND/IMPD or NDA submissions.
- You have exemplary teamwork and interpersonal skills, organizational and self-management skills, including planning and execution of meetings and presentations.
- You have a good understanding of the drug development process, management of network of CRO’s, work in cross functional teams.
- You show proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.)