Dr. Claus Benno Cordes
Mainz
Summary
Broadly experienced in the pharmaceutical industry with a comprehensive understanding of all aspects of manufacturing. Demonstrated expertise in quality assurance, quality control, and CMO management. Extensive knowledge in development activities, devices, regulatory compliance, project and team management. Experienced leader with a strong background in guiding teams and successfully managing complex projects to achieve strategic objectives.
Overview
23
23
years of professional experience
Work History
Consult Transfergesellschaft Sanofi
01.2025 - Current
Head of Quality Cluster Team
Sanofi
01.2017 - 12.2024
- Involved in all areas of manufacturing at CMOs
- Analytical method development and validation
- Stability Studies
- Process validations
- Regulatory dossier generation
- Product transfers
- Quality Agreement negotiations
- Management of team of up to 12 internal (9 AT, 3 Tarif) + 5 external employees, ensuring quality and accuracy of work
- Budget planning and cost monitoring
- Risk management and escalation
- Establishing investigation reports including root cause analysis
- Quality project representative
- Success: Finalization of Pharmaton Remediation project (securing product brand of 100 million annual sales)
Head of Product Quality Management Team
Sanofi
10.2014 - 12.2016
- Tasks and responsibilities are comparable to current position
- Specialty: Participation in in-depth quality evaluation (duration 8 days) of BI device site (Dortmund)
Project Manager in Sterile Manufacturing Plant
Sanofi
01.2013 - 09.2014
- Coordination of implementation of new products in sterile manufacturing site and lifecycle management of established products
- Creation and follow up of project plans
- Coordination of root cause investigations and related CAPA implementation
- Success: Implementation of Toujeo (Insulin) ampoule filling on ZA4
Head of Laboratory
Sanofi
09.2007 - 12.2012
- Analytical project representative e.g., in phase III project
- Development and validation of analytical methods for drug products and APIs
- QC testing of starting materials, intermediates, drug substance und drug product
- Interface to Quality Assurance Department; improvement of quality system of the department
- Success: Creation of all analytical parts for a submission dossier for a sterile injectable drug product
- Specialty: Invention of different medical devices (leading to patent application)
Senior Quality Manager
Altana Pharma /Nycomed
10.2004 - 09.2007
- Quality assurance and control
- Announced as Head of quality control according to AMWHV at RP Tübingen
- Set up and approval of specifications for drug products, drug substances, devices, and packaging materials used in clinical trials
- Control and approval of validation protocols and reports
- Responsible for release of API batches
- Representative of the QC and QA in multi-disciplinary project teams in the development of different drug product forms with internal and external partners for inhalation sprays (MDI), nasal sprays, tablets and capsules, suspension for instillation into the lung
- Specialty: Responsible for device development used in a clinical trial
Head of QC Laboratory
Steigerwald Arzneimittelwerk GmbH
01.2002 - 09.2004
- Project manager in quality control division within R&D
- Success: Generation of complete CMC dossier part for renewal of Iberogast (most important product of the company); finally, renewal was granted
Education
PhD - Chemistry
Johannes Gutenberg University
07.2001
Diploma - Chemistry
Johannes Gutenberg University
10.1997
Skills
- Analytic
- Team Management
- CMO Management
- Development
- Quality Assurance
- Project Management
- Teamwork and collaboration
- Problem-solving
Languages
English
German
Squash, Volleyball
Weekly with friends
Family
Married, 4 children
Timeline
Consult Transfergesellschaft Sanofi
01.2025 - Current
Head of Quality Cluster Team
Sanofi
01.2017 - 12.2024
Head of Product Quality Management Team
Sanofi
10.2014 - 12.2016
Project Manager in Sterile Manufacturing Plant
Sanofi
01.2013 - 09.2014
Head of Laboratory
Sanofi
09.2007 - 12.2012
Senior Quality Manager
Altana Pharma /Nycomed
10.2004 - 09.2007
Head of QC Laboratory
Steigerwald Arzneimittelwerk GmbH
01.2002 - 09.2004
Diploma - Chemistry
Johannes Gutenberg University
PhD - Chemistry
Johannes Gutenberg University
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