Erfahrener Toxikologe mit über 15 Jahren Erfahrung in Forschung und Entwicklung für Arzneimittel (insbesondere Inhalationstherapeutika).
Aktualisiert am 22.01.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 22.01.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Projektmanagement
Aerosolwissenschaft
Arzneimittelentwicklung

Einsatzorte

Einsatzorte

Marburg (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2016 ? today: Leading non-clinical project teams


Role: Senior Manager Toxicology

Customer: CSL Behring Innovation GmbH, Marburg, Germany


Tasks:

  • Leading non-clinical project teams and designing/supervising studies covering efficacy, pharmacokinetics, biodistribution and safety assessment of novel biologic pipeline assets with additional focus on inhaled and respiratory therapeutics.
  • Responsible for GLP-compliant toxicology studies, including preclinical safety assessments for regulatory submissions (FDA, EMA, MHRA, PMDA).
  • Providing scientific and strategic advice in drug development, particularly in translational aspects and biomarker identification.
  • Coordinating and collaborating with CROs and academic partners to conduct in-vitro and in-vivo studies, ensuring quality, timelines, data integrity, and compliance with global standards (GLP/GMP).
  • Drive regulatory submission readiness, authoring comprehensive nonclinical reports, safety narratives, and integrated data summaries for global filings.
  • Spearhead cross-functional collaborations with Clinical, CMC, Regulatory Affairs, and Device/Delivery teams to align nonclinical strategy and accelerate development milestones.
  • Presenting results at international conferences/scientific meetings.

2011 ? 2016: Directed design, execution, and reporting


Role: Nonclinical Study Director

Customer: Charles River Laboratories, Edinburgh, UK


Tasks:

  • Directed design, execution, and reporting of GLP toxicology studies across multiple species and dosing routes, including inhalation, intranasal, local and systemic exposure (oral, IV & SC).
  • Delivered scientific consultation and data interpretation supporting client decisions on project progression, hazard identification, risk management and regulatory packages (incl. REACH).
  • Ensured adherence to GLP, ICH, and regulatory requirements, and successfully supported inspections and audits.
  • Led cross-disciplinary teams, mentored scientists, and implemented Lean/Six Sigma process improvements to streamline study operations.

2008 ? 2011: Assisting conduct and analysis of non-clinical studies


Role: Assistant Scientist / Project Leader / Trainee Study Director
Customer: Charles River Laboratories, Edinburgh, UK

Tasks:

  • Assisting conduct and analysis of non-clinical studies with a focus on toxicology, pharmacokinetics, and biomarker development.
  • Developing and validating SOPs for quality assurance in GLP studies.
  • Hands-on experience with aerosol technology and formulation/sample analytics for drugs and chemical entities.

2007 ? 2008: Preparation of tissue samples


Role: Pathology Technician

Customer: Charles River Laboratories, Edinburgh, UK


Tasks:

  • Preparation of tissue samples from toxicology studies for histopathological evaluation.
  • GLP compliant data recording and documentation.

Aus- und Weiterbildung

Aus- und Weiterbildung

2002 ? 2006

BSc Hons Biomedical Science

Edinburgh Napier University

HPC-accredited degree ? Hons Project: Protein Bioinformatics


2001 ? 2002

Access to Science (Biology)

Edinburgh Telford College

Kompetenzen

Kompetenzen

Top-Skills

Projektmanagement Aerosolwissenschaft Arzneimittelentwicklung

Produkte / Standards / Erfahrungen / Methoden

Short Profile

  • Experienced registered toxicologist with 15+ years? experience across nonclinical research, safety assessment, and global regulatory strategy in pharmaceutical development and agrochemical registration. Recognized expert in inhaled and respiratory therapeutics, with deep domain knowledge in pneumology, immunology, haematology, and transplantation.
  • Extensive experience spanning efficacy, pharmacokinetics, biodistribution, preclinical toxicology, and biomarker identification for biologics (gene therapies, mRNA, ASOs, antibodies, proteins), small molecules, formulation excipients and agrochemicals. Proven expertise in inhaled drug development, including aerosolization, exposure systems, dosimetry, device selection, and CMC/regulatory deliverables.
  • Demonstrated track record of leading multidisciplinary, international teams; managing CRO and academic partnerships; and contributing to business development and portfolio decisions. Patent holder, regular invited speaker at international conferences and published author in peer-reviewed journals.


Technical expertise

Project management, report/regulatory document preparation and review, aerosol science and device delivery systems, understanding of formulation technology and bio analytics, validated data systems, Microsoft Office, intermediate level German language.

Einsatzorte

Einsatzorte

Marburg (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2016 ? today: Leading non-clinical project teams


Role: Senior Manager Toxicology

Customer: CSL Behring Innovation GmbH, Marburg, Germany


Tasks:

  • Leading non-clinical project teams and designing/supervising studies covering efficacy, pharmacokinetics, biodistribution and safety assessment of novel biologic pipeline assets with additional focus on inhaled and respiratory therapeutics.
  • Responsible for GLP-compliant toxicology studies, including preclinical safety assessments for regulatory submissions (FDA, EMA, MHRA, PMDA).
  • Providing scientific and strategic advice in drug development, particularly in translational aspects and biomarker identification.
  • Coordinating and collaborating with CROs and academic partners to conduct in-vitro and in-vivo studies, ensuring quality, timelines, data integrity, and compliance with global standards (GLP/GMP).
  • Drive regulatory submission readiness, authoring comprehensive nonclinical reports, safety narratives, and integrated data summaries for global filings.
  • Spearhead cross-functional collaborations with Clinical, CMC, Regulatory Affairs, and Device/Delivery teams to align nonclinical strategy and accelerate development milestones.
  • Presenting results at international conferences/scientific meetings.

2011 ? 2016: Directed design, execution, and reporting


Role: Nonclinical Study Director

Customer: Charles River Laboratories, Edinburgh, UK


Tasks:

  • Directed design, execution, and reporting of GLP toxicology studies across multiple species and dosing routes, including inhalation, intranasal, local and systemic exposure (oral, IV & SC).
  • Delivered scientific consultation and data interpretation supporting client decisions on project progression, hazard identification, risk management and regulatory packages (incl. REACH).
  • Ensured adherence to GLP, ICH, and regulatory requirements, and successfully supported inspections and audits.
  • Led cross-disciplinary teams, mentored scientists, and implemented Lean/Six Sigma process improvements to streamline study operations.

2008 ? 2011: Assisting conduct and analysis of non-clinical studies


Role: Assistant Scientist / Project Leader / Trainee Study Director
Customer: Charles River Laboratories, Edinburgh, UK

Tasks:

  • Assisting conduct and analysis of non-clinical studies with a focus on toxicology, pharmacokinetics, and biomarker development.
  • Developing and validating SOPs for quality assurance in GLP studies.
  • Hands-on experience with aerosol technology and formulation/sample analytics for drugs and chemical entities.

2007 ? 2008: Preparation of tissue samples


Role: Pathology Technician

Customer: Charles River Laboratories, Edinburgh, UK


Tasks:

  • Preparation of tissue samples from toxicology studies for histopathological evaluation.
  • GLP compliant data recording and documentation.

Aus- und Weiterbildung

Aus- und Weiterbildung

2002 ? 2006

BSc Hons Biomedical Science

Edinburgh Napier University

HPC-accredited degree ? Hons Project: Protein Bioinformatics


2001 ? 2002

Access to Science (Biology)

Edinburgh Telford College

Kompetenzen

Kompetenzen

Top-Skills

Projektmanagement Aerosolwissenschaft Arzneimittelentwicklung

Produkte / Standards / Erfahrungen / Methoden

Short Profile

  • Experienced registered toxicologist with 15+ years? experience across nonclinical research, safety assessment, and global regulatory strategy in pharmaceutical development and agrochemical registration. Recognized expert in inhaled and respiratory therapeutics, with deep domain knowledge in pneumology, immunology, haematology, and transplantation.
  • Extensive experience spanning efficacy, pharmacokinetics, biodistribution, preclinical toxicology, and biomarker identification for biologics (gene therapies, mRNA, ASOs, antibodies, proteins), small molecules, formulation excipients and agrochemicals. Proven expertise in inhaled drug development, including aerosolization, exposure systems, dosimetry, device selection, and CMC/regulatory deliverables.
  • Demonstrated track record of leading multidisciplinary, international teams; managing CRO and academic partnerships; and contributing to business development and portfolio decisions. Patent holder, regular invited speaker at international conferences and published author in peer-reviewed journals.


Technical expertise

Project management, report/regulatory document preparation and review, aerosol science and device delivery systems, understanding of formulation technology and bio analytics, validated data systems, Microsoft Office, intermediate level German language.

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