Chemical PR&D, Manufacturing (APIs, GMP), CMC-Project Management, Tech Transfers, Process Validation, Reg. Submission support, DDs, Consultancy
Aktualisiert am 21.08.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 21.08.2025
Verfügbar zu: 100%
davon vor Ort: 40%
Life Science
Good Manufacturing Practice
Chemische Verfahrenstechnik
CMC-Project Management
Technology Transfer
Due Dilligences
Chemical PR&D
Process Validation
Regulatory Submission support
Outsourcing
Supply Chain Management
German
English
French

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 10 months
2024-02 - now

BD and PM Consulting

Founder and Chief Executive
Founder and Chief Executive
  • Interims Tech Transfer Project-manager for a Swedish Orphan Drug company
  • CMC-Advisor of a Swiss Biotech Start-up company (large molecules)
  • Consultant on BD- and Technical Projects of a Chinese CDMO
  • Technical Advisor to a Chinese pharmaceutical company
Active Pharmaceutical Ingredients
1 year 11 months
2022-03 - 2024-01

Supporting successfully

Head of CDCM-API (Vice President)
Head of CDCM-API (Vice President)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 9 Technical Project Leaders plus one API-Safety-Project Leader
  • Annual budget responsibility: 40-50 mio. CHF
  • Supporting successfully NDA submission of PIVLAZ in Japan and South Korea
  • API-launch- and commercial supply for PIVLAZ and QUIVIVIC
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
2 years 11 months
2019-04 - 2022-02

GMP compliant API manufacturing

Head of CDCM-API (Sr. Director)
Head of CDCM-API (Sr. Director)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 7 Technical Project Leaders plus one API-Safety-Expert
  • Annual budget responsibility: 40-50 mio. CHF
  • Process Validation Clazosentan and Lucerastat
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
1 year 9 months
2017-06 - 2019-02

GMP compliant API manufacturing globally

Head of Chem Dev API (Director)
Head of Chem Dev API (Director)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 6 Technical Project Leaders
  • CMC-leadership for various early clinical phase development projects.
  • Supporting successfully several IND submissions for clinical trials
  • Annual budget responsibility: 30-40 mio. CHF
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
3 years 4 months
2014-03 - 2017-06

responsibility for one commercia

Sr. Technical Project Leader (Associate Director), Drug Substance Operations
Sr. Technical Project Leader (Associate Director), Drug Substance Operations
  • Managing commercial and development Drug Substance Manufacturing with CMOs globally
  • Budget responsibility for one commercial product: about 8 mio. CHF with an impact on 100 mio. sales
  • Budget responsibility for several development products in the range of 2-3 mio. CHF p.a. per project
  • Immediate signing power: 400 kCHF
Actelion Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
6 months
2013-09 - 2014-02

Improve Plant, Plant Performance Expert

Improve Plant, Plant Performance Expert for Vit. B6, Vitamin D3, Carotenoid Intermediates and Multi-Purpose Plant operations.
  • Small CAPEX projects for maintenance and continuous process improvement up to 1 mio. CHF
DSM Nutritional Products Ltd. (CH)
Assignment to Grenzach Site, Germany
4 months
2013-05 - 2013-08

Re-patriation and small projects evaluation

DSM Nutritional Products Ltd. (CH)
Kaiseraugst, Switzerland
2 years 10 months
2010-07 - 2013-04

DSM Biotechnology Process R&D-Centre

  • Planning, establishing and starting-up Biotech Process R&D-Centre and R&D team in Shanghai (LCP 2.5 mio. EUR);
  • Line responsibility: Hiring and coaching 15 Biotech Scientists including my own successor as Head of the Centre
  • PMP-Silver basic.
  • Technology Support for manufacturing sites of DSM Food Specialties and DSM-Sinochem Pharmaceuticals in China
DSM Nutritional Products Ltd. (CH)
International assignment to Shanghai, P.R.C.
11 months
2009-08 - 2010-06

Nutritional Products Chemical Process

  • DSM Nutritional Products Chemical Process R&D-Centre (Director); Start-up and expansion of Chemical Process R&D-labs and team (LCP 2.2 mio. EUR)
  • Hiring, training and coaching of Process Improvement team for DSM Vitamin manufacturing sites in China
DSM Nutritional Products Ltd. (CH)
International Assignment to Shanghai, P.R.C

Aus- und Weiterbildung

Aus- und Weiterbildung

11 years 8 months
1978-09 - 1990-04

Chemistry and Physics

PhD, University of Heidelberg
PhD
University of Heidelberg

Studies in Chemistry and Physics

PhD Thesis in Organic Chemistry

Position

Position

Self-employed consultant / freelancer

Kompetenzen

Kompetenzen

Top-Skills

Life Science Good Manufacturing Practice Chemische Verfahrenstechnik CMC-Project Management Technology Transfer Due Dilligences Chemical PR&D Process Validation Regulatory Submission support Outsourcing Supply Chain Management

Schwerpunkte

Process Chemistry
Experte
Project Management
Experte
GMP-Manufacturing
Experte
Outsourcing
Experte
Due Dilligence
Fortgeschritten

Forschung & Entwicklung

QbD
Fortgeschritten
Quality Risk Management
Fortgeschritten

Produktion & Fertigung

Outsourcing
Experte
GMP-compliance
Fortgeschritten
Tech Transfer
Experte
Process Validation
Experte

Branchen

Branchen

Pharmaceutical and Fine Chemical Industry

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 10 months
2024-02 - now

BD and PM Consulting

Founder and Chief Executive
Founder and Chief Executive
  • Interims Tech Transfer Project-manager for a Swedish Orphan Drug company
  • CMC-Advisor of a Swiss Biotech Start-up company (large molecules)
  • Consultant on BD- and Technical Projects of a Chinese CDMO
  • Technical Advisor to a Chinese pharmaceutical company
Active Pharmaceutical Ingredients
1 year 11 months
2022-03 - 2024-01

Supporting successfully

Head of CDCM-API (Vice President)
Head of CDCM-API (Vice President)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 9 Technical Project Leaders plus one API-Safety-Project Leader
  • Annual budget responsibility: 40-50 mio. CHF
  • Supporting successfully NDA submission of PIVLAZ in Japan and South Korea
  • API-launch- and commercial supply for PIVLAZ and QUIVIVIC
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
2 years 11 months
2019-04 - 2022-02

GMP compliant API manufacturing

Head of CDCM-API (Sr. Director)
Head of CDCM-API (Sr. Director)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 7 Technical Project Leaders plus one API-Safety-Expert
  • Annual budget responsibility: 40-50 mio. CHF
  • Process Validation Clazosentan and Lucerastat
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
1 year 9 months
2017-06 - 2019-02

GMP compliant API manufacturing globally

Head of Chem Dev API (Director)
Head of Chem Dev API (Director)
  • Managing Idorsia's outsourcing of GMP compliant API manufacturing globally
  • Leading a team of 6 Technical Project Leaders
  • CMC-leadership for various early clinical phase development projects.
  • Supporting successfully several IND submissions for clinical trials
  • Annual budget responsibility: 30-40 mio. CHF
Idorsia Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
3 years 4 months
2014-03 - 2017-06

responsibility for one commercia

Sr. Technical Project Leader (Associate Director), Drug Substance Operations
Sr. Technical Project Leader (Associate Director), Drug Substance Operations
  • Managing commercial and development Drug Substance Manufacturing with CMOs globally
  • Budget responsibility for one commercial product: about 8 mio. CHF with an impact on 100 mio. sales
  • Budget responsibility for several development products in the range of 2-3 mio. CHF p.a. per project
  • Immediate signing power: 400 kCHF
Actelion Pharmaceuticals Ltd. (CH)
Allschwil, Switzerland
6 months
2013-09 - 2014-02

Improve Plant, Plant Performance Expert

Improve Plant, Plant Performance Expert for Vit. B6, Vitamin D3, Carotenoid Intermediates and Multi-Purpose Plant operations.
  • Small CAPEX projects for maintenance and continuous process improvement up to 1 mio. CHF
DSM Nutritional Products Ltd. (CH)
Assignment to Grenzach Site, Germany
4 months
2013-05 - 2013-08

Re-patriation and small projects evaluation

DSM Nutritional Products Ltd. (CH)
Kaiseraugst, Switzerland
2 years 10 months
2010-07 - 2013-04

DSM Biotechnology Process R&D-Centre

  • Planning, establishing and starting-up Biotech Process R&D-Centre and R&D team in Shanghai (LCP 2.5 mio. EUR);
  • Line responsibility: Hiring and coaching 15 Biotech Scientists including my own successor as Head of the Centre
  • PMP-Silver basic.
  • Technology Support for manufacturing sites of DSM Food Specialties and DSM-Sinochem Pharmaceuticals in China
DSM Nutritional Products Ltd. (CH)
International assignment to Shanghai, P.R.C.
11 months
2009-08 - 2010-06

Nutritional Products Chemical Process

  • DSM Nutritional Products Chemical Process R&D-Centre (Director); Start-up and expansion of Chemical Process R&D-labs and team (LCP 2.2 mio. EUR)
  • Hiring, training and coaching of Process Improvement team for DSM Vitamin manufacturing sites in China
DSM Nutritional Products Ltd. (CH)
International Assignment to Shanghai, P.R.C

Aus- und Weiterbildung

Aus- und Weiterbildung

11 years 8 months
1978-09 - 1990-04

Chemistry and Physics

PhD, University of Heidelberg
PhD
University of Heidelberg

Studies in Chemistry and Physics

PhD Thesis in Organic Chemistry

Position

Position

Self-employed consultant / freelancer

Kompetenzen

Kompetenzen

Top-Skills

Life Science Good Manufacturing Practice Chemische Verfahrenstechnik CMC-Project Management Technology Transfer Due Dilligences Chemical PR&D Process Validation Regulatory Submission support Outsourcing Supply Chain Management

Schwerpunkte

Process Chemistry
Experte
Project Management
Experte
GMP-Manufacturing
Experte
Outsourcing
Experte
Due Dilligence
Fortgeschritten

Forschung & Entwicklung

QbD
Fortgeschritten
Quality Risk Management
Fortgeschritten

Produktion & Fertigung

Outsourcing
Experte
GMP-compliance
Fortgeschritten
Tech Transfer
Experte
Process Validation
Experte

Branchen

Branchen

Pharmaceutical and Fine Chemical Industry

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