Drug Substance Manager | Drug Substance Manager*
AiCuris Anti-infective Cures AG
Job Summary
As a Drug Substance Manager, you will play a crucial role within the CMC management team, overseeing the entire lifecycle of drug substances for clinical and commercial supply. Your daily tasks will involve managing Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs) for API manufacturing, particularly small molecules and oligonucleotides. You will ensure product quality, manage technical drug substance development aspects like analytics and impurity profiling, and work closely with QA/QC on quality incidents and documentation. This position is attractive for professionals seeking to contribute to regulatory filings in the US and EU, manage supply chains, and support the preparation for commercial phases, all within a company dedicated to developing anti-infective therapeutics.
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