Expertin
Frau Dr. Lioba Lobmayr
Lioba Lobmayr has founded her own company Aquila Pharma - pharmaceutical quality from the eagle's perspective. Aquila Pharma offers consultancy services and interim management for Pharma, Biotech & innovative Startups in the areas Quality & Compliance, Project Management, Funding Management. She continues to give seminars and lectures and to mentor students at IMC FH Krems (University of Applied Sciences) in Biopharmaceuticals, Quality Control and Analytical Testing for the Masters Programme in Pharmaceutical and Medical Biotechnology. She has held several positions in pharmaceutical and biotech industry including production, quality control and assurance, as a Qualified Person, as well as in project & funding management, regulatory and medical affairs at companies including Baxter, Sandoz, Boehringer Ingelheim, AVIR Green Hills Biotechnology, Novartis Pharma, Activartis. In her professional career she successfully managed the development of a life-attenuated influenza vaccine from pre-clinic to phase 2, the regulatory approval process of the first biosimilar products, GMP-conform implementation of manufacture & QC and batch release of complex biopharmaceutical products (pDNA, proteins, monoclonal antibodies) as well as radio-pharmaceuticals (PET/CT-tracers). Graduating from the University of Vienna and Max F. Perutz Laboratories in Chemistry as MSc and as a PhD in Biochemistry, she did her PostDoc at the University of Pennsylvania, School of Medicine, Philadelphia. After postgraduate studies of Pharmaceutical Quality Managment at the University of Vienna she was certified as Qualified Person (Industrial Pharmacist acc. to AMBO2009, Dir 2001/83/EC) in 2008 by the Austrian AGES / BASG. With completing the General Consulting Program at Incite GmbH she is Certified Management Consultant and with the Women Leadership Program Zukunft.Frauen she qualifies as Director of Supervisory Boards.
Expertise
- Biotechnologie: Herstellung, Qualitätskontrolle und Freigabe von biotechnologisch hergestellten Arzneimittel-Chargen (Industrie-Pharmazeutin / Sachkungige Person entspr. AMBO2009, Dir 2001/83/EC). Pharmazeutische Produkt-Entwicklung von Biopharmazeutika. Optimierung, Scale-up und Implementierung von GMP Herstellprozessen und Analytik von Biopharmazeutika. Programm und Projekt Management.
- Forschungs- und Innovationsmanagment: Beantragung, Management sowie Berichten (wissenschaftlich, wirtschaftlich) von industriellen Forschungs- und Entwicklungsprojekten. Einzelprojekte, Konsortialprojekte.
- Humanmedizin: Krebsimmuntherapie basierend auf dendritischen Zellen (komplementär zu Chirurgie, Strahlen-, Chemotherapie) - Entwicklung, Projektleitung, Fördermanagement
Schlagworte
- Biochemie
- Industrie Pharmazie
- Qualified Person
- Pharmaceutical Product Development
- Projekt Management
Verfügbar für
Beruflich
Oberes Management
Tätigkeitsbereiche:- Wirtschaft / Industrie
Ausbildung
Universität (1999)
Chemie
Zusatzausbildung(en)
ULG Pharmazeutisches Qualitätsmanagmenent & Zertifizierung als Sachkundige Person (Industrie-Pharmazie)
Akademische Unternehmensberaterin (Incite General Consulting Program)
Zukunft Frauen (BMVIT, WKO, IV)
Weitere Fachrichtungen, weitere Ausbildungen
Chemie / Biochemie Diplom 1995, Mag.rer.nat.
Biochemie / Molekularbiologie 1999, Dr.rer.nat
Sprachen
Mehr Details
Referenzen
Auszeichnungen / Preise
Publikationen
CEO, Owner
Unternehmensberatung Pharma & Biotech
Kontakt
Letzte Aktualisierung: 12.05.2023