Daniel Samson PhD, MBA

Synthetic Protein and Peptide Manufacturing Strategy, Emerging Technologies. Emerging Technologies (ET) brings next‑generation therapeutics from concept to scale at Novo Nordisk. We advance synthetic protein & peptide APIs and their intermediates/key starting materials, expand global manufacturing capacity, and drive productivity—enabled by strong scientific leadership and deep collaboration across CMC & Product Supply, MSAT, QA/QC, and manufacturing sites/CDMOs worldwide.

As a General Manager and Vice President in Thermo Fisher´s Small Molecule Unit of the Drug Substance Division, P&L accountable for the sites in Linz, Austria, and Regensburg, Germany. The Active Pharmaceutical Ingredients (API) facilities provide process development and chemical production of intermediates and APIs for clinical and commercial supply under cGMP and ISO, combined with the ability to solve complex challenges for our customers. o Production scales ranging from few kg to thousands of metric tons o Development, optimization, Tech Transfer, and scale-up of chemical processes, QbD approach (Quality by Design)

Improving patients' lifes with Genetic Medicine. Passionate about sustainable manufacturing at largest scales, innovation, and digital transformation, which I applied to intensify the processes and technologies for drug substance production. I have lead the growth strategy and vertical integration for an oligonucleotides business unit, leveraging my intrapreneurial mindset and IMD Executive MBA education. Additionally, I am thought leader and speaker in state-of-the-art manufacturing science and technology (MSAT) and Chemistry, Manufacturing, Controls (CMC). Role: •Member of Senior Corporate Management team •Member of Reserach Committee •Overseeing all Oligonucleotide Operations, Process R&D, Production; Business Development activities Areas: •P&L responsibility •Growth strategy, ramp-up, and vertical integration •Capacity increase, CAPEX projects, Greenfield projects •Business model innovation, change management, CDMO vs. CMO transformation •Innovation in Manufacturing Science & Technology (MSAT)

Role: •Member of Site Mangement •Vice President Production of active pharmaceutical ingredients / APIs & diagnostics, peptides, siRNA, DNA (oligonucleotides), complex small molecules, manufacturing science and technology / MSAT Areas: •Operational Excellence and Smart Factory initiatives (state-of-the-art engineering, automation, digital transformation, Industry 4.0 •Innovation management •Operations Strategy, strategy execution, growth initiatives •Operational Technology (OT), change management) •CMC development, scale-up, validation and commercialization of manufacturing processes for the largest, therapeutically relevant peptide drugs, such as GLP-1 analogs for the treatment of type 2 diabetes, obesity and related conditions •Handling of highly potent active pharmaceutical ingredients (HAPI)

Roles: •Director, Senior Director, Department Head, up to 12 direct reports Areas: •Chemistry, Manufacturing, Controls (CMC) of Active Pharmaceutical Ingredients (API) •Operational excellence, lean six sigma, 5S, good manufacturing practice (GMP), key performance indicators (KPI) •Health, Safety, Environment (HSE) and Quality regulations, FDA inspections •Chemical production for developmental & commercial pharmaceuticals •Industrial-scale chromatography and freeze-drying (lyophilization) of bulk drug substance

Role: •Implement an MSAT organization •Build, lead and develop a Chemistry - Manufacturing - Controls process R&D lab Areas: •Project handovers from R&D to production, project phase appropriate optimization of manufacturing processes (including starting materials, process intermediates, final API, process capability) •Late stage process optimization, formulation/lyophilization development

Role: •Integration of a new site, M&A, brownfield projects •Project management in technology transfer from Swiss site to US site Areas: •Leadership of cross-functional matrix teams, CAPEX projects, process validation

Role: •Production Scientist Areas: •Technology and knowledge transfer from Bachem AG, Switzerland to Bachem UK, Ltd, St. Helens, United Kingdom

•Lab Head Process Optimization Lab, ICH Q11, Quality by Design (QbD), Design of Experiments (DoE), process risk assessments (FMEA)

•Leading Active Pharmaceutical Ingredients production team, cGMP purification, preparative chromatography, lyophilization of complex biomolecules, peptides and small proteins.

•Leading Active Pharmaceutical Ingredients production team, cGMP synthesis of complex biomolecules, peptides and small proteins.

Role: •Research Scientist - Heterocyclic Chemistry Areas: •Teaching Assistant to the Chairs of Physical Chemistry and Organic Chemistry •Focus areas Organic Synthesis, Heterocyclic Chemistry, Transition Metal Catalysis, Optical Spectrosopy, NMR Spectroscopy, Fluoresence Dyes