Heiner Zindel

Biotech Process Development and Manufacturing

CONELIS expert Heiner Zindel

BPR BioPharm Resources GmbH

Kriens, Switzerland

German, English

Services offered worldwide

www.bpr-biopharm-resources.ch

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Offers

  • Business plans or parts of them
  • Strategy or development of a strategy applicable to your objectives and needs
  • Assessment of existing product and/or technology portfolio
  • Execution of technical due diligence
  • Marketing analysis and concepts
  • Concepts for process developing and controlled API production up to phase III
  • Analysis, process reviews and optimizations
  • Qualification and validation concepts

Qualifications

Dual qualification in life sciences and economics combined with wide range of experience gained in over fifteen years working in drug development of several biologics for clinical phases and production for market.

Education:

Chemist HTL/FH
pgD in Biotechnology
NDS FH in Technical Information Technology
MBA BioMedTech

Experience:

Head USP, DSP and Deputy of plant manager, Werthenstein Chemie AG (Schering-Plough USA)
Head R&D, Bioengineering AG in Wald
Project manager Biotechnology, Siegfried Ltd in Zofingen
Head DSP, Siegfried-Biologics GmbH in Kleinmachnow (D)

As Consultant for:
Avesta Biotherapeutics, Hameln rds GmbH, Eufets GmbH, Hameln pharmaceuticals GmbH, Pharma Resources GmbH, EBEWE GmbH (Sandoz);
Built up a biotechnology CRO, Establishment of API Processes, Project management, Validations & Qualifications, Process Evaluation and implementation of a new business area, Member of Business Development, Business plans for GMP establishment of API Processes

Areas of Expertise:

CMC