Project Lead Analytical Chemistry Pharma (m/f/d)
- Degree (MSc, PhD) in chemistry or pharmacy with specialisation in analytics
- 5-10 years of Pharma Industry experience: analytical development or QC for DP or DS
- Small molecules experience
- Expertise on CMC documentation and involvement in IMPD filings
- Project management capabilities, able to influence and drive project success
The Project Lead Analytical Chemistry serves as interface, liaison and point of contact for all quality control related analytical activites within his projects, performed at external partners under GMP.
In this role, you are responsible for the definition, oversight and technical guidance of all analytical development and related activities for one late phase or some early phase development project(s) mainly performed at CRO/CMO.
You select and manage providers of analytical services, including analytical services embedded in CMOs and monitor these for all CMC analytical activities for small molecules from starting material to DS and DP. You 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.
You actively contribute to CMC and project teams, and ensure alignment of analytical activities with the project development plans and contribute to specification preparation in accord with current regulatory requirements. You will also draft and review CMC sections of regulatory submissions along with other functional groups. Participate in preparation of responses to regulatory agency questions.