Analytical Development Pharma RD Basel

CMO project coordination in Basel 1 year contract

The Analytical Development Manager will oversee monitor and drive outsourced analytical studies for chosen projects. You will act as interface liaison manager and point of contact for all analytical activites in clinical stage projects phase I to III. This role is to coordinate and align the projects for innovative drug development according to international GMP standards. You will be responsible for * definition oversight and technical guidance of all analytical development in your projects

• related activities for development projects performed at CRO/CMO site
• selection and management of providers of analytical services
• monitor analytical activities from starting material to DS and DP.
• design and oversee the development validation and transfer of phase appropriate analytical methods for raw material IPC DS and DP testing and ensure the availability of all required documentation
• Write analytical overview reports and support writing/updating of development sections of regulatory documents (e.g. CTD).
• Support budgeting and cost monitoring as well as lean processes in work order and billing

Your profile * Degree (PhD) in biochemistry chemistry or pharmacy with specialisation in analytics

• 3 years of GMP regulated industry experience: Analytical development/ QC

• KnowHow in analytical development for peptides or large molecules
• Experience with CRO CDMO partners and technical communication
• project management capabilities able to influence and drive project success

You are very structured in your working approach adopt a solutionoriented approach and have a highly accurate vision of analytical data both from a scientific and regulatory perspective. You have excellent English skills. Our customer is an innovative pharmaceutical company located in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs.