13.10.2026 aktualisiert
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Senior Biotech/Pharma Consultant & Interim Manager | QP | ATMP | GMP | Produktion & Qualität
Greven, Deutschland
Weltweit
Ph.D. (Dr. rer. nat.), Institute for Experimental Dermatology, University of Munster, GermanyÜber mich
International erfahrener Biotech/Pharma-Berater, Interim Manager, QP - 25+ Jahren Erfahrung. ATMP, Zell-/Gentherapie, Biologika, GMP-Produktion, QA/QRM, Aseptik, Audits, Remediation und Ramp-up. Operative Führung und QP-Verantwortung in Europa, USA und Indien. Leitender Berater, Mares ITX GmbH
Skills
Qualified Person (QP) for Advanced Therapies
Expertise as Qualified Person under EU and UK law for ATMPs, biologics, and tissue preparations. QP batch release and pharmacovigilance support for multiple clients, including iPSC and rAAV gene therapy programs.
GMP & Aseptic Manufacturing
Extensive knowledge of EU Grade A-D cleanrooms, brownfield remediation, and greenfield build-out. Leadership of aseptic-plant improvements, validations, and team building across biologics and advanced-therapy manufacturing sites.
Regulatory & Audit Management
Deep experience with PIC/S audits, EMA/MHRA inspection readiness, GMO licensing, and GenTSV. Successful delivery of facility audits with zero findings and GMO/vaccine-facility licensing under active regulatory scrutiny.
Quality Risk Management (QRM)
Implementation of QRM frameworks, batch record review, deviation and CAPA management, and GDP supply-chain controls across multiple client organizations.
Cell & Gene Therapy Modalities
Subject-matter expertise in rAAV, iPSC, MSC, and cord-blood-derived products, supporting manufacturing, quality, and regulatory functions for advanced-therapy manufacturers and CDMOs.
GMP Audit Training & Gap Assessments
Delivery of GMP/PIC-S audit training and gap assessments with closure plans for clients across Europe, the US, UK, India, and South Korea.
Technology Scouting
Multi-year technology scouting advisory engagements covering cell culture and chemistry products and processes for clients including ICL and Evonik.
Jira-Based Deviation Tracking
Implementation of Jira-based deviation tracking systems within QC and FAT facility environments to improve compliance and traceability.
Genetic Engineering & GMO Regulatory Compliance
Leadership of genetic-engineering workstreams and investigations, supporting government inspections and corporate audits, and obtaining required GMO licenses.
R&D and Manufacturing Leadership
20+ years of in-house executive, R&D, quality, and manufacturing leadership across biologics, advanced therapies, and tissue-engineering programs in Europe, the US, UK, and India.
Expertise as Qualified Person under EU and UK law for ATMPs, biologics, and tissue preparations. QP batch release and pharmacovigilance support for multiple clients, including iPSC and rAAV gene therapy programs.
GMP & Aseptic Manufacturing
Extensive knowledge of EU Grade A-D cleanrooms, brownfield remediation, and greenfield build-out. Leadership of aseptic-plant improvements, validations, and team building across biologics and advanced-therapy manufacturing sites.
Regulatory & Audit Management
Deep experience with PIC/S audits, EMA/MHRA inspection readiness, GMO licensing, and GenTSV. Successful delivery of facility audits with zero findings and GMO/vaccine-facility licensing under active regulatory scrutiny.
Quality Risk Management (QRM)
Implementation of QRM frameworks, batch record review, deviation and CAPA management, and GDP supply-chain controls across multiple client organizations.
Cell & Gene Therapy Modalities
Subject-matter expertise in rAAV, iPSC, MSC, and cord-blood-derived products, supporting manufacturing, quality, and regulatory functions for advanced-therapy manufacturers and CDMOs.
GMP Audit Training & Gap Assessments
Delivery of GMP/PIC-S audit training and gap assessments with closure plans for clients across Europe, the US, UK, India, and South Korea.
Technology Scouting
Multi-year technology scouting advisory engagements covering cell culture and chemistry products and processes for clients including ICL and Evonik.
Jira-Based Deviation Tracking
Implementation of Jira-based deviation tracking systems within QC and FAT facility environments to improve compliance and traceability.
Genetic Engineering & GMO Regulatory Compliance
Leadership of genetic-engineering workstreams and investigations, supporting government inspections and corporate audits, and obtaining required GMO licenses.
R&D and Manufacturing Leadership
20+ years of in-house executive, R&D, quality, and manufacturing leadership across biologics, advanced therapies, and tissue-engineering programs in Europe, the US, UK, and India.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2014
Sprachen
DeutschMutterspracheEnglischMuttersprache
Projekthistorie
Head of Production / Qualified Person (QP) – zellbasiertes ATMP
Branche: Biotechnologie / ATMP / Cell Therapy
Rolle: Head of Production / Qualified Person
Status: laufendes Mandat
Leitung der Produktion und QP-Verantwortung für ein Unternehmen im Bereich zellbasierter Advanced Therapy Medicinal Products.
Aufgaben / Leistungen:
- Produktionsleitung und QP-Verantwortung
- Unterstützung einer erfolgreichen GMP-Inspektion
- Optimierung der aseptischen Produktionsstätte
- Validierungsaktivitäten
- Aufbau und Weiterentwicklung des Teams
- Unterstützung neuer Entwicklungs- und Produktionsaktivitäten
Technologien/Skills: ATMP, Cell Therapy, QP, GMP, Aseptic Processing, Manufacturing, Validation, Inspection Readiness, Team Leadership
Branche: Pharma / Biotechnologie
Rolle: GMP Auditor / Senior Consultant
Projektumfeld: International
Durchführung von GMP-Audits und Gap Assessments für verschiedene Kunden und Organisationen.
Aufgaben / Leistungen:
- GMP-/PIC/S-Audits
- Gap Assessments
- Bewertung von Produktions- und Qualitätssystemen
- Identifikation regulatorischer und operativer Compliance Gaps
- Vorschläge für geeignete Maßnahmen zur Gap Closure
- Audits in Europa, USA, UK, Indien und Südkorea
Technologien/Skills: GMP Auditing, PIC/S, Gap Assessment, Quality Systems, Compliance, CAPA/Remediation, International Auditing
QP / Senior SME – rAAV-Gentherapie
Branche: Biopharma / Gene Therapy
Rolle: Qualified Person / Senior SME
Projektumfeld: Deutschland / USA
QP- und Senior-SME-Unterstützung eines rAAV-Gentherapieprogramms für ophthalmologische Anwendungen mit internationaler Zusammenarbeit zwischen Deutschland und den USA.
Aufgaben / Leistungen:
- Bewertung von Drug Substance (DS) und Drug Product (DP)
- QP-Freigabe mehrerer Chargen
- Zentrale Rolle bei einer Investigation
- Koordination zwischen Teams und Unternehmen in Deutschland und den USA
- Audit eines deutschen CMO
- Audits von US-Partnern/CMOs
Technologien/Skills: rAAV, Gene Therapy, QP, Batch Release, GMP, Investigations, CMO Management, GMP Auditing, International Coordination
Zertifikate
Projektleiter Gentechnik
Gewerbeaufsichtsamt Göttingen2020