Education and Certifications
MSc BA – Business Administration and Bioentrepreneurship
PhD – Organic and Medicinal Chemistry
MSc – Chemical Engineering (Organic Chemistry)
Diplom-Ingeniør – Organic Synthesis
Certified Project Manager
(Expert PM (Implement), PRINCE2, PMBOK-based methodologies)
Certified ScrumMaster (SAFe)
Regulatory and GMP Training
ICH, FDA, and GMP frameworks
Experience
CMC and Operational Management
15+ years working with small molecules, bioconjugates, linkers, mAbs and regulated development environments across R&D, CMC, clinical, and commercial stages.
Delivered full CMC packages (IND/IMPD) for Phase 1 ADC programs, including QMS, manufacturing and regulatory support.
Cross-Functional and External Collaboration
Extensive 12+ years of experience working with external partners, CROs, CDMOs, and CMOs across Europe, US, and Asia.
Facilitated project and CDMO alignment between QA, QC, RA, Clinical Supply, and Non-Clinical teams throughout early, late and commercial phases in Biotech and Pharma.
Led innovation and cost-optimization initiatives, improving documentation flows and exceeding KPI targets in Novo Nordisk and Ascendis Pharma.
Additional Achievements
Managed >10M USD program budgets (ADC) and negotiated significant cost reductions using data-driven approaches.
Due diligence
IP strategies
Quality Management and Governance Systems
Led CMC strategy and execution for oncology ADC Ph1 programs at Adcendo, managing mAb, linker-payload, DS, DP flows.
Established commercial production, LCM activities and introduced process verification settings at Ascendis Pharma.
Regulatory Compliance Leadership (INDs/MAAs, NDA/MAA/CN, BLA/MAA/CN)
Supported regulatory CMC submissions thereof Ph3/IND/IMPD and NDA/MAA/CN for oral excipient used for commercial product on market and BLA/MAA/CN for linker used for bioconjugate product on market. Also authored/reviewed full CMC IND/IMPD modules 2.3/3 for ADC Ph1 (mAb/LP/ADC DS/ ADC DP) and another ADC Ph1 (LP) and Ph2 (DS peptide intermediate).
Managed cross-functional governance and decision support for global filings of Module 2.3 and 3.
Strong on LP and DS writing, control strategies, API SM strategies, characterisation and robust process evaluations.