Innovation – early & late phase - Injectables
Our client is an innovative pharmaceutical company located in the centre of Basel. Intensive research and development activities have led to a promising pipeline of potential marketable products. The dynamic and rapidly growing team based in Basel primarily focuses on project management and collaborates with an international network of partners.
In this role you report to the Chief Development Officer and are responsible for a proactive and efficient Project Management in all CMC matters. You define and implement the adequate regulatory strategy for CMC projects in collaboration with Regulatory Affairs and with the support of external advice. You plan, initiate and control analytical CMC studies, select vendors and manage projects. You serve as the main contact person for CDO and CMO vendors. You determine appropriate in-process controls and criteria for release and analytics and manage the projects till up-scaling into commercial batch production. In this context you work closely with the Senior Quality Assurance Manager in CMC issues and manage and maintain CMC documentation (CTD, IND, IMPD). Interaction with competent authorities might be requested from time to time.
- PhD in chemistry, biochemistry, pharmacy, biotechnology or related area
- 7-10 years experience in pharma development drug product
- Experience in CMC-related aspects of injectables, small molecules and peptides
- Experience in NDA submission, approval and Health Authority interactions is a plus
This very interactive project management role requires excellent communication and organizational skills. You are able to show leadership in vendor and project related situations and know how to present convincing arguments to effectively push your projects forward. You are recognized as well organized and structured, with a result-driven and straightforward approach. Mastering the necessary “soft skills” to achieve high-performance teamwork for geographically dispersed partners is a key challenge of the position.
We are looking forward to get in touch with you.
Contact us on our website: online application.
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