Drug Substance Manager | Drug Substance Manager*
AiCuris Anti-infective Cures AG
Job Summary
As a Drug Substance Manager, you will be a key member of the CMC management team, playing a critical role in supporting all development projects. Your day-to-day will involve managing clinical and commercial drug supply, ensuring product quality, and overseeing relationships with Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs). A significant part of your responsibilities will also include preparing comprehensive CMC documentation for regulatory submissions. This position offers the opportunity to work with innovative experts, contribute to life-changing anti-infective therapeutics, and benefit from a collaborative culture that values scientific excellence and individual growth.
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