Dr. Giani Oancea

• Lead and delegate study start-up and regulatory submission activities in various countries (DACH, APAC, Latin America) • Overseeing transition activities and from Dir 2001/20/EC to Reg (EU) 536/2014 • Lead and support oncological studies with BfS applications (DEU) and Radiation Dossier (CHE) • Builds and maintains relationships with clients, MAHs, and key personnel within customer companies • Provides input for bids supports relevant budget oversight and reconciliation

• Assuming regulatory responsibilities and preparation of submission dossier to CA, EC and other applicable local bodies • Acting as a hub for central intelligence for clinical studies and oversee all functional areas while ensuring quality delivery • Combining novel clinical trial designs, industry-leading operational and medical experts • Prepare regulatory strategies and identify regulatory requirements for submissions • Knowledge of the current regulations (ICH-GCP, Reg EU No 536/2014, CTIS, CESP)

• 189 Agreements and Budgets finalized (on average 4.25 months/per agreement) • 22 Studies, 18 Sponsors, Exceptional Awards 4 (Colitis ulc., Ph. II; Parkinson’s Dis. Ph. II, Arthritis Ph. IV, Hepatic Dis. Ph IV) • Development of Master Agreement Initiative

• Development and GMP production of cell- and tissue therapeutics • Manage internal inspection (2), and GMP validation audits (2, ISO 9001) • SQL Data Management and generation of monthly QPR reports (14) • Sales controlling and blood depot-management (> 20 blood products/week)

• Design, controlling and evaluating of the hygiene management systems-QM (ISO 9001) • Development and maintenance of SOPs (15) and GxP training (4) • QC for GMP production of human cornea and heart valves)

• Manage GMP manufacture of human blood-derived products • Preparing the entire documentation for the license manufacture of a medical product • Application for a clinical study (Phase 3) at Paul-Ehrlich-Institute; interaction with regulatory bodies • Three years of experience in migrating and executing new work procedure templates (SOPs)

Molekularbiologie Überexpression (Genexpression in Insektenzellen-Sf9, Konstruktion von rekombinanten Baculoviren für die Expression in Insektenzellen, BAC-TO-BAC Baculovirus Expression System) Proteinanalytik (Proteinreinigung, Proteinbestimmungen, enzymatische Aktivitätstests, immunologische Techniken, Chemische Modifikationen von Proteinen, Immunoblotting, SDS-PAGE, Co-Immunoprecipitation Dynabeads Protein A/G) Molecular modeling

• Epidemiological studies on antibiotics resistance genes and „broad host range“-plasmids in the environment

• Development of new proteomics approaches (2D SDS-PAGE and MALDI-TOF) for identification of new selenoproteins from anaerobic bacteria

• Learning of new methods for cell cultivation in microhollowspheres • Scale-up studies with microencapsulated cells in small bioreactors (plant, insect and human fibroblasts)

• Quality control (QC) of antibiotic’s production (nystatin, penicillin, streptomycin) • Scale-up batch bioreactors (10 L) studies for finding the optimal microbial growth parameters

• Data management and CRF • Regulatory affairs (ICH-GCP, AMG, GCP-V, FDA) • Pharmacovigilance (AE, SAE, SUSAR,IP)

SAP Finanzbuchhaltung: Geschäftsprozesse im Financial Accounting SAP Controlling: Geschäftsprozesse im Management Accounting SAP - Anwender SAP ERP 6.0 Zertifizierung Internes Rechnungswessen / Kostenstellen und Innenaufträge