Dr. Harald Hufsky MBA

Interim management in chemical/pharma industry: - Filling of immediate vacancies in key leadership roles for bridging succession planning - SWOT analysis for product portfolios and the underlying value chain in TechOps, efficiency analysis and benchmarking - Turnaround management (ensuring cash flow, restructuring with focus on competitiveness) CMC management for pharma development Management of (external) manufacturing Project management for pharmaceutical chemical production capacity expansion

# Management aller CMC Lifecycle Aktivitäten: - Erstellung/Implementierung von CMC Projektplänen - Definition von Quality Target Produkt Profil (QTPP) in Kooperation mit DMPK - Koordination von DS Synthese- und DP Formulierungsentwicklung - Unterstützung von Regulatory Affairs bei Erstellung von IMPD and CTA # Externe Herstellung von RSMs, Zwischenprodukten und DS: - Leitung von TechTransfer und Scale-up - Qualifizierung geeigneter CDMOs - Verhandlung von Service-Agreements - Leistungsbeurteilung

Geschäftsführung der dt. Niederlassung des jap. Chemiekonzerns Central Glass Co., Ltd: - Gesamtverantwortung (inkl. P&L) - Strat. Weiterentwicklung des gesamten Standorts: Infrastruktur, FuE, GMP Produktion, QC und QA - Koordination der Prozessentwicklung mit Mutterkonzern und des Vertriebs mit Partnerfirmen - Steigerung der Produktivität (Lean) - Kontinuierliche Verbesserung, Kaizen - Weiterbildung der Mitarbeitenden Leider musste ich aus familiären Gründen die Leitung dieser großartigen Firma abgeben.

Increase of process understanding and strengthening of process capabilities by data trending, statistical analysis and implementation of improvements; ensuring a continued state of validation; oversight on regulatory CMC consistency across sites

- Management of efficient GMP manufacture of chemical intermediates and drug substances - International tech transfers into new production buildings: design and commissioning of new plant - Launch of new products: Pipeline manufacturing planning in close cross-functional co-operation with development, HSE, QA, QC, engineering, SCM, DRA - Preparation and execution of internal and external (RHI, FDA) GMP and HSE audits - Chemical advisor for the fire brigade (Novartis/IFRB and Kanton BL, BS)

- Chemical manufacture of sterile, non-sterile and highly hazardous chemical intermediates and drug substances - Leading multi-disciplinary teams (Finance, Engineering, QA/QC, HSE) for the introduction of new products from development into production - Leading operational launch teams with up to 20 team members - Structured root-cause analysis while investigating deviations; implementation of sustainable corrective and preventive actions

- Manufacture of intermediates and drug substances by applying extraction and chromatographic techniques - Planning of agricultural raw material inventory, considering seasonal and regional influances - Transfer of process know-how in outsourcing projects

- Synthesis and testing of anti-tumor agents (inhibitors of the PDGF-receptor) on the basis of investigating structure-activity-relationships - Co-operation with partners from industry: Synthesis of small molecule tubulin-inhibiting and anti-angiogenic compounds on lab-scale for in-vitro and in-vivo testing - Organisation of practical courses and respective tutorials for students of Pharmaceutical Studies

Organisational Behaviour, Marketing, Economics, Finance, Financial Risk Management, Accounting, Negotiation, Project Management, Strategic Planning

Structure-activity based molecular modelling and synthesis of anti-cancer agents (signal-transduction inhibitors, tubulin inhibitors, anti-angiogenic compounds)