Clinical Research, Research & Development, GMP, Companion Diagnostics, Regulatory Services
Aktualisiert am 25.06.2024
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 25.06.2024
Verfügbar zu: 100%
davon vor Ort: 30%
Biotechnik/Medizintechnik
Biotechnologie
Clinical Research
agiles Projektmanagement
Good Manufacturing Practice
Statistik

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
nicht möglich

Projekte

Projekte

2022 - today : Project Leading


Role: Project Lead, Pfizer Pharma US

Customer: Pfizer Pharma US, on request

2019 - today: Various project tasks

Role: Founder/CEO

Customer: on request

2020 - 2023: SMILE (Small Incision Lenticule Extraction)


Role: Project Lead

Customer: Carl Zeiss Meditec AG

2019 - 2023: Companion Diagnostics


Role: Head Companion Diagnostics

Customer: BioNTech Germany

2015 - 2021: Companion Diagnostics


Customer: Roche Sequencing, San Jose,US

2015 - 2019: Science Operations

Role: Manager Science Operations

Customer: TIB Molbiol GmbH/Roche Diagnostics GmbH

2014 - 2016: Clinical Science Management

Role: Clinical Science Manager/EMEA

Customer: CSL Behring GmbH

2008 - 2016: Science Operations


Role: Manager Science Operations

Customer: Thermo Fisher Scientific

2011 - 2012: Science Management


Role: Senior Science Manager

Customer: Amgen Germany

2010 - 2011: Clinical Operations


Role: Clinical Operations Lead

Customer: Pfizer Pharma GmbH Germany

2008 - 2010: Clinical Science Management


Role: Clinical Science Manager

Customer: Amgen Head Office for Central & Eastern Europe, Vienna

2008 - 2007: Clinical Operations


Role: Supervisor Clinical Operations

Customer: Profil Institute for Clinical Research, Inc. San Diego, CA

2007 - 2005:


Role: Co-Founder

Customer: on request

2000 - 2005: Clinical Research


Customer: Profil Institute for Metabolic Research, Neuss, Germany

Clinical Research

Role: Clinical Research Manager

Customer: Charite Berlin Centre for Metabolic Research

Independent Consulting

Role: Independent Consultant
Customer: Life Science Innovation Consulting BV

Aus- und Weiterbildung

Aus- und Weiterbildung

  • MSc Translational Medicine
  • MSc Biostatistic, RN

Kompetenzen

Kompetenzen

Top-Skills

Biotechnik/Medizintechnik Biotechnologie Clinical Research agiles Projektmanagement Good Manufacturing Practice Statistik

Produkte / Standards / Erfahrungen / Methoden

Technical skills and competences

  • More than 26 molecules developed and fully approved from FDA/EMA (3x Prix Galien Award with Amgen (denosumab/romiplostim) and inclusive Orphan drugs for CSL Behring FDA/EMA.
  • More than 200 assays and multiplex assays developed under ISO 13458 /98/79EG and fully approved and registered for (Roche Diagnostics/Thermo Fisher Scientific/TIB Molbiol GmbH, BioNTech, IsoRea AB)
  • Responsible and full oversight for development of the largest Headquater from Amgen in Central and Eastern Europe, responsible as manager for 10 countries.Drug Discovery for Bayer Pharma(HDXperts)
  • Development of Exubera Pfizer Pharma/Profil Institute for Clinical Research (FDA/EMA) First Aptamer developed for Pfizer and approved in Degenerative Macular Edema AMD
  • Bioanalytic: Invitro,-Invivo, validation studies, methodology quality assessment;
  • Development of Modular multiplex IVD medical devices
  • Expert Companion Diagnostics(CDx), GMP, MDR, IVDR

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
nicht möglich

Projekte

Projekte

2022 - today : Project Leading


Role: Project Lead, Pfizer Pharma US

Customer: Pfizer Pharma US, on request

2019 - today: Various project tasks

Role: Founder/CEO

Customer: on request

2020 - 2023: SMILE (Small Incision Lenticule Extraction)


Role: Project Lead

Customer: Carl Zeiss Meditec AG

2019 - 2023: Companion Diagnostics


Role: Head Companion Diagnostics

Customer: BioNTech Germany

2015 - 2021: Companion Diagnostics


Customer: Roche Sequencing, San Jose,US

2015 - 2019: Science Operations

Role: Manager Science Operations

Customer: TIB Molbiol GmbH/Roche Diagnostics GmbH

2014 - 2016: Clinical Science Management

Role: Clinical Science Manager/EMEA

Customer: CSL Behring GmbH

2008 - 2016: Science Operations


Role: Manager Science Operations

Customer: Thermo Fisher Scientific

2011 - 2012: Science Management


Role: Senior Science Manager

Customer: Amgen Germany

2010 - 2011: Clinical Operations


Role: Clinical Operations Lead

Customer: Pfizer Pharma GmbH Germany

2008 - 2010: Clinical Science Management


Role: Clinical Science Manager

Customer: Amgen Head Office for Central & Eastern Europe, Vienna

2008 - 2007: Clinical Operations


Role: Supervisor Clinical Operations

Customer: Profil Institute for Clinical Research, Inc. San Diego, CA

2007 - 2005:


Role: Co-Founder

Customer: on request

2000 - 2005: Clinical Research


Customer: Profil Institute for Metabolic Research, Neuss, Germany

Clinical Research

Role: Clinical Research Manager

Customer: Charite Berlin Centre for Metabolic Research

Independent Consulting

Role: Independent Consultant
Customer: Life Science Innovation Consulting BV

Aus- und Weiterbildung

Aus- und Weiterbildung

  • MSc Translational Medicine
  • MSc Biostatistic, RN

Kompetenzen

Kompetenzen

Top-Skills

Biotechnik/Medizintechnik Biotechnologie Clinical Research agiles Projektmanagement Good Manufacturing Practice Statistik

Produkte / Standards / Erfahrungen / Methoden

Technical skills and competences

  • More than 26 molecules developed and fully approved from FDA/EMA (3x Prix Galien Award with Amgen (denosumab/romiplostim) and inclusive Orphan drugs for CSL Behring FDA/EMA.
  • More than 200 assays and multiplex assays developed under ISO 13458 /98/79EG and fully approved and registered for (Roche Diagnostics/Thermo Fisher Scientific/TIB Molbiol GmbH, BioNTech, IsoRea AB)
  • Responsible and full oversight for development of the largest Headquater from Amgen in Central and Eastern Europe, responsible as manager for 10 countries.Drug Discovery for Bayer Pharma(HDXperts)
  • Development of Exubera Pfizer Pharma/Profil Institute for Clinical Research (FDA/EMA) First Aptamer developed for Pfizer and approved in Degenerative Macular Edema AMD
  • Bioanalytic: Invitro,-Invivo, validation studies, methodology quality assessment;
  • Development of Modular multiplex IVD medical devices
  • Expert Companion Diagnostics(CDx), GMP, MDR, IVDR

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