Manager

• CMO/ CDMO/ CRO management for API manufacturing of small molecules and Tides (mainly Oligonucleotides) for clinical study supply and early commercial phases
• Management of all aspects of technical drug substance development (eg, analytics, solid state assessment, impurity profiling, route finding)
• Close interaction with QA/QC to manage CAPAs, change controls, quality incidents, writing of SOPs and participating in audits as technical expert
• Supply chain management of APIs, Regulatory Starting Materials, and other critical reagents
• Support of selection and evaluation of suitable CMOs/ CDMOs/ CROs for GMP manufacture and testing
• Cost of good assessment, support of commercial phase preparation, and post-approval activities
• Support of regulatory fillings in US and EU (eg, CTD module 3) and review of quality documentation relevant for manufacturing and testing (eg, MBR, validation protocols)

Drug Substance Manager

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