ONDREJ PRETO
Bratislava,Slovakia
Summary
Analytical and Quality professional with 4+ years of experience in GMP-regulated biopharmaceutical environments across Quality Control, Process Analytical Technology, and Quality Assurance. Specialized in analytical method validation, qualification and transfer, external laboratory coordination, and lifecycle oversight of parenteral drug products. Experience spans commercial GMP batch release testing, stability programs, statistical process monitoring (CpK, control limits), deviation and OOS investigations, and validation documentation aligned with ICH/FDA/EMA expectations. Strong technical writing skills and cross-functional collaboration within QC, QA, CMC, and supply chain environments.
Overview
5
5
years of professional experience
1
1
Certification
Work history
Quality Assurance (GMP QC & Audit Management)
HAMELN RDS
Modra
2023.01 - 2026.02
- QA role within a commercial GMP facility performing API manufacturing, QC batch release testing, and stability testing for marketed finished dosage forms (fill & finish performed at external site).
- QA oversight within GMP QC release environment supporting QP-certified batches
- Review and approval of deviations and change controls (authorized QA approver; training phase ongoing)
- Participation in OOS investigations within QC laboratory scope including laboratory error assessments and confirm/reject evaluations
- Preparation of statistical analyses for Product Quality Reviews (PQRs), including historical batch trending, control limit calculation, and CpK/process capability analysis
- Generation of graphical performance overviews and process performance indicators for lifecycle monitoring
- Planning and follow-up of internal and supplier audits; CAPA tracking and effectiveness verification
- Collaboration with QC, manufacturing and supply chain to ensure inspection readiness and regulatory compliance
- Impact: Direct exposure to commercial GMP operations including API production, batch release testing, statistical process monitoring, and structured quality system governance.
Independent PhD Research & Laboratory Work
Bratislava
2025.02 - 2026.01
- Independently designed and executed structured laboratory research project
- Bioreactor-based cultivation and controlled sampling workflows
- Coordination of external sequencing service providers ensuring traceability and structured data transfer
- Statistical data processing, interpretation and structured documentation
- Relevance: Demonstrates continuous analytical activity, vendor coordination, and disciplined data evaluation — not a career gap.
Sr. Research Associate
HOOKIPA Biotech GmbH
Vienna
2022.07 - 2025.01
- Developed, qualified, and transferred analytical methods (HPLC/UPLC, SEC-MALS, DLS, NTA, particle imaging techniques)
- Technical coordination and scientific review of external GMP validation plans and validation reports
- Primary technical interface with contract laboratory organizations (CLOs) for release and stability testing of -80 C parenteral viral vector drug products
- Structured feedback cycles with suppliers regarding validation scope, statistical evaluation, and acceptance criteria
- Author/reviewer of stability protocols and reports (long-term, accelerated, in-use, compatibility, comparability)
- Contributor to cross-functional specification discussions and analytical lifecycle strategy
- Evaluation and implementation of new analytical technologies
- Impact: Strengthened validation robustness and ensured technical soundness of externally performed GMP testing prior to QA approval.
Sr. Specialist, Quality Control
HOOKIPA Biotech GmbH
Vienna
2020.10 - 2022.06
- Review and approval of analytical testing ensuring cGxP compliance and data integrity
- Batch release documentation and CoA preparation
- Deviations, OOS investigations, CAPAs and risk assessments
- Analytical troubleshooting and continuous improvement initiatives
- QC point-of-contact for major international partnership
- Contribution to IMPD/IND regulatory documentation
Education
MSc - Biotherapeutics
University College Dublin
BSc - BioPharmaceutical Science
University of Sunderland
Doctor of Philosophy - Genetics
Comenius University
Bratislava 2020.09 -
Skills
- Analytical Method Lifecycle
- Validation, qualification & transfer (protocols, reports, risk-based assessment)
- Scientific review of external GMP validation documentation
- Method robustness, comparability & bridging evaluations
- Statistical data evaluation and acceptance criteria assessment
- Parenteral Product & Stability Oversight
- -80 C ultra-deep frozen parenteral viral vector drug products
- Commercial GMP release and stability testing coordination
- Long-term, accelerated, in-use, compatibility & comparability studies
- Quality Systems & Governance
- Deviations, OOS, CAPAs, change control
- Root cause analysis & confirm/reject laboratory investigations
- Product Quality Reviews (PQR/APQR)
- Statistical trending, control limit calculation, CpK analysis
- Audit preparation & follow-up
- QA document review and approval responsibility
- Cross-Functional & External Collaboration
- QC, QA, CMC, PD, supply chain
- Contract laboratory organizations (CLO/CRO)
- Contribution to IMPD/IND documentation
Certification
- Good Manufacturing Practice (GMP)
- Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis
- Lean Management
- Project Management Basics
LANGUAGES
English — native-like proficiency
German — beginner
Timeline
Independent PhD Research & Laboratory Work
2025.02 - 2026.01
Quality Assurance (GMP QC & Audit Management)
HAMELN RDS
2023.01 - 2026.02
Sr. Research Associate
HOOKIPA Biotech GmbH
2022.07 - 2025.01
Sr. Specialist, Quality Control
HOOKIPA Biotech GmbH
2020.10 - 2022.06
Doctor of Philosophy - Genetics
Comenius University
2020.09 -
BSc - BioPharmaceutical Science
University of Sunderland
MSc - Biotherapeutics
University College Dublin