CMC Drug Product Development Lead
The core purpose of the job is to manage the drug product development and clinical bulk supplies for various development projects within the CMC department.
As drug product development (Sr) Lead , you will be responsible for
- the drug product development and bulk supply strategy and execution thereof for various development projects
- drug product – formulation development for preclinical safety studies and clinical supplies
- (bulk) manufacturing of development batches and GMP batches for clinical purposes
- evaluation and review of development data (composition/process/PK data) and adjustment of formulation/process as needed
- evaluation of stability data in cooperation with Analytical Lead and further adjustment of the strategy and plan as needed
- preparation of drug product development source documents for clinical trial applications (quality section) and prepare responses to regulatory questions
- selection and management of contractors executing the drug product development / manufacturing 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, Analytical Lead and Drug Substance Lead) to build the CMC development plan and ensure execution thereof
- You have a Master degree in pharmaceutical or bio-engineering or equivalent by experience.
- You have 5 -10 years experience in drug development, especially in formulation development and are experienced in the preparation of drug product development reports for the CM&C section of 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.)