Dr. Harald Hufsky MBA
Freiberuflich, Sr. Pharma Consultant, Dr. Harald Hufsky Pharma Consulting
Großraum Basel - Lörrach, Deutschland
Über mich
In 2021 I regretfully had to resign as Managing Director of Central Glass Germany for family reasons, after having been with this great company for almost 5 years. Today I live in the Basel region again and support pharmaceutical companies in Switzerland or abroad that have a need for interim management / project management in areas such as business management, site/plant management, technical operations or CMC management. I have 20+ years of experience in the chemical and pharmaceutical industry (Novartis, Central Glass Germany, Idorsia), with a Ph.D. (“Dr.rer.nat”) degree in Medicinal Chemistry and an MBA degree in Business Management. Throughout manifold leadership positions in pharma, I developed strong core competencies in general management, R&D and technical operations. These include (external) GMP manufacturing, Lean operations, quality assurance, CMC project management, technical transfer, scale-up, validation/qualification, change control and drug life cycle management.
Werdegang
Berufserfahrung von Harald Hufsky MBA
Bis heute 7 Monate, seit Dez. 2023
Sr. Pharma Consultant
Dr. Harald Hufsky Pharma Consulting
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
2 Jahre und 3 Monate, Sep. 2021 - Nov. 2023
Director, Sr. Technical Project Leader and CMC Leader
Idorsia Pharmaceuticals Ltd
# 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
4 Jahre und 6 Monate, März 2017 - Aug. 2021
Geschäftsführer / Managing Director
Central Glass Germany GmbH
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.
1 Jahr, März 2016 - Feb. 2017
Product Stewart MS&T
Novartis Pharma AG, Basel, Switzerland
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
5 Jahre und 1 Monat, Feb. 2011 - Feb. 2016
Production & Transfer Manager
Novartis Pharma AG, Basel, Schweiz
- 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)
7 Jahre, Feb. 2004 - Jan. 2011
Senior Process Manager WKL-376/377
Novartis Pharma AG, Basel, Schweiz
- 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
2 Jahre, Feb. 2002 - Jan. 2004
Process Manager WSJ-316
Novartis Pharma AG, Basel, Schweiz
- 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
Ausbildung von Harald Hufsky MBA
4 Jahre und 10 Monate, März 2006 - Dez. 2010
Business Management
Edinburgh Business School
Organisational Behaviour, Marketing, Economics, Finance, Financial Risk Management, Accounting, Negotiation, Project Management, Strategic Planning
3 Jahre und 9 Monate, Nov. 1997 - Juli 2001
Medicinal Chemistry
Universität Regensburg
Structure-activity based molecular modelling and synthesis of anti-cancer agents (signal-transduction inhibitors, tubulin inhibitors, anti-angiogenic compounds)
5 Jahre und 9 Monate, Nov. 1991 - Juli 1997
Chemistry
Universität Regensburg & Leeds University
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Japanisch
Grundlagen