Dipl.-Ing. Stefan Schleifer
Angestellt, CMC Regulatory and Operations Manager, invIOs Innovative Immune Oncology GmbH (formerly: APEIRON)
Klosterneuburg/Groningen (NL), Österreich
Werdegang
Berufserfahrung von Stefan Schleifer
Bis heute 3 Jahre und 6 Monate, seit Jan. 2021
CMC Regulatory and Operations Manager
invIOs Innovative Immune Oncology GmbH (formerly: APEIRON)
3 Jahre, Jan. 2018 - Dez. 2020
Manager, Regulatory Affairs Lead
Patheon - Now part of Thermo Fisher Scientific
Regulatory Affairs Lead at multi-product (recombinant protein/mAb) CMO's manufacturing site successfully transforming from development/clinical-only manufacture to commercial operations.
8 Monate, Mai 2017 - Dez. 2017
Manager, RA CMC Lead EU Facilities
Shire
RA CMC Lead for international tech transfer/internalization projects (plasma, immunology)
11 Monate, Juni 2016 - Apr. 2017
Manager Regulatory Affairs
Shire Pharmaceuticals
Heading plant RA team. Alignment with global RA strategy. Interface Regulatory Affairs <> Operations & Quality functions. Execution/coordination of CMC/F&E section authorship. US/EU/international submission strategy. Experience in CH, CA, CN, JP submission preparation/local regulations. Change control. CTD/eCTD. FDA Level I & II GMP inspections. MoH inspections from various countries. BLA (CBE/CBE30, PAS, Annual Report), EU/international MAH. Regulatory guidance for manufacturing plant.
6 Monate, Jan. 2016 - Juni 2016
Regulatory Affairs Manager
Baxalta Innovations GmbH
Interface Regulatory Affairs/other functions. Execution/coordination of CMC/F&E section authorship. US/EU/international submission strategy. Change control. CTD/eCTD. MoH/FDA inspections. BLA (CBE/CBE30, PAS, Annual Report), EU/international MAH. Regulatory guidance for manufacturing plant. CAPA. Compliance/Quality improvement. Project support.
8 Monate, Mai 2015 - Dez. 2015
Regulatory Affairs Specialist
Baxalta Innovations GmbH
Interface Regulatory Affairs/other functions, execution/coordination of CMC section authorship, US/EU submission strategy, change control, eCTD, CBE30, PAS, Annual Report, regulatory guidance for facility, CAPA
4 Monate, Jan. 2015 - Apr. 2015
Regulatory Affairs
Baxter
Interface Manufacturing/Regulatory Affairs, execution/coordination of CMC section authorship, US/EU submission strategy, change control
2 Jahre und 6 Monate, Juli 2012 - Dez. 2014
Quality Specialist Life Cycle Management
Baxter
Submissions of plasmatic and recombinant therapeutics (legacy and development products), vaccines. Creation and review of CTD-Module 2/3 documents. Development of guidelines on QbD content in submission documents. Participation in QbD projects (workshops, document ownership). Inititiation of submission/process-related Changes. Routine handling of changes/deviations and authority requests/questions. Audit experience (FDA, other authorities). Completion of MEGRA Regulatory Affairs trainings.
1 Jahr und 7 Monate, Apr. 2009 - Okt. 2010
Bachelor Student/Diploma Student/Scientific Contributor
CD Laboratory for Antibody Engineering (F-star Biotechnology Ltd)
Research work (Fcab technology); multiple biochemical and molecular biotechnological methods
3 Jahre und 5 Monate, Apr. 2003 - Aug. 2006
Musik-Redakteur
IndieGO/INDIE Magazine
Verantwortlich für Koordination und Gestaltung der Sparte Musik. Interviews/Rezensionen/Artikel.
2 Jahre, Jan. 2003 - Dez. 2004
Rettungssanitäter
Rotes Kreuz Klosterneuburg
Zivildienst und ehrenamtliche Tätigkeit
Praktikant
Lebensmittelversuchsanstalt
3 Praktika im Gesamtausmaß von sechs Monaten.
Ausbildung von Stefan Schleifer
2 Jahre und 8 Monate, Mai 2009 - Dez. 2011
Biotechnologie
BOKU
Antibody Engineering
4 Jahre und 8 Monate, Sep. 2004 - Apr. 2009
Lebensmittel- und Biotechnologie
BOKU
Antibody Engineering
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
Italienisch
Grundlagen