Basic

Dr. Frank Hanakam

Freelancer/Self-employed, Geschäftsführer, Senior Consultant, Hanakam-Consulting

Wörthsee / München, Germany

Skills

Langjährige Erfahrung (> 15 Jahre) in der Entwicklung und Produktion von Bio-Therapeutika bzw. Diagnostika [GMP
CMC
Regulatory
biogenerics
biosimilars
comparability
Process Development
Analytical Methods Development
Qualification
Validation
Project Management
COGS calculation
Manufacturing
Processes
Regulatory Compliance
Outsourcing Manufacturing
Due Diligence
Contract Negotiation
Technology Transfer
Relationship Management
Budgetary Control
Quality
Team Formation
Personnel Development
Organizational Structuring]

Timeline

Professional experience for Frank Hanakam

  • Current 12 years and 7 months, since Dec 2008

    Geschäftsführer, Senior Consultant

    Hanakam-Consulting

    siehe auch: www.hanakam-consulting.com

  • 1 year and 8 months, Apr 2007 - Nov 2008

    Vice President, Biotech Development

    Synthon BV

  • 10 years and 8 months, Sep 1996 - Apr 2007

    Vice President, Process Development

    Micromet AG

Educational background for Frank Hanakam

  • Biologie / Mikrobiologie / Business

    Mainz, Tübingen, Milton Keynes - Universitäten/Business School

    Mikrobiologie Genetik Biochemie Messtechnik & Elektronik

Languages

  • German

    -

  • English

    -

  • French

    -

Wants

Biotech Management
interims Management
hands-on Support und Freelance Projekte im Bereich: R&D und Biopharma-Produktion
CMC
Regulatory Affairs
Quality
Auditing
Analytik- und Prozessentwicklung
Qualifizierung
Validierung
Tech-Transfer
Comparability Dossiers
FMEA
Modul 3
Filing IND
IMPD
CTD => Erstellung von Zulassungsunterlagen

Interests

Reisen
Mountainbiken
Windsurfen
Segeln

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