Drug Substance Manager | Chemist (m/w/d)
AiCuris GmbH & Co. KG
Job Summary
As a Drug Substance Manager, you will play a crucial role in the CMC management team, overseeing clinical and commercial drug supply for development projects. Your daily responsibilities will involve managing CMOs/CDMOs/CROs for API manufacturing of small molecules and oligonucleotides, ensuring product quality, and supporting all technical drug substance development aspects like analytics and impurity profiling. You will also interact closely with QA/QC for CAPAs and change controls, manage supply chains for critical reagents, and support regulatory filings in the US and EU. This position is ideal for a professional with a strong background in pharmaceutical CMC development who thrives in a collaborative environment and is passionate about translating scientific innovation into patient-focused solutions.
Required Skills
Education
PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
Experience
- At least 5 years of post-graduate professional experience in the pharmaceutical / biotech industry
- Profound experience in CMC development for early- and late-phase programs, specifically with drug substance related activities
- Exposure to the principles of QbD (Quality by Design) and DoE (Design of Experiment)
- Experience in CMO/CDMO/CRO management and collaboration with external partners
- Experience with supporting regulatory filings in US and EU
- Sound expertise in GMP-compliant drug substance manufacturing and testing, including validation and transfer
Languages
Additional
- Not specified