Lukáš Hrbek, Ph.D.
Project Manager
Stockach
Summary
Accomplished Project Manager with a proven track record at Optima Pharma Containment, adept in cross-functional coordination and management consulting. Excelled in delivering complex solutions, enhancing quality assurance processes, and driving significant business growth. Skilled in GxP knowledge and fostering team collaboration, consistently achieving project goals through strategic planning and risk management.
Overview
8
8
years of professional experience
10
10
years of post-secondary education
3
3
Languages
Work History
Project Manager
Optima Pharma Containment GmbH
02.2024 - Current
- Managing 7 projects of manufacturing aseptic or high potent isolators for top pharma companies.
- Planning activities across experts till SAT and maintaining list of opened point during the whole project
- Identifying plans and resources required to meet project goals and objectives.
- Managing risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Senior Consultant
Deloitte Advisory
01.2023 - 01.2024
- Developed a new and start-up Life Science & Health Care team in Prague focusing on pharmaceutical sector.
- Implemented Document Management System Veeva as for a European Pharma player.
- Collaborated with internal teams to develop customized solutions that addressed unique client needs.
Consultant
Novartis
03.2020 - 12.2022
- Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
- Managed client relationships through regular check-ins and updates on project progress.
- Developed innovative strategies for clients, resulting in increased revenue and business growth.
GMP & Biorisk Specialist
Praha Vaccines
10.2017 - 03.2020
- As a specialist in technical support department, I was liaising between Quality Assurance and Manufacturing
- Responsible for finalizing URS for the whole start-up business: Manufacturing of Inactivated Polio Vaccine
- Responsible for change control processes and supporting in design qualification, FMEA analysis and creating SOPs.
- Supporting creation of Biorisk Management System reflecting requirements and guidelines from WHO towards Polio vaccine
CQV Engineer
Lab&Pharma
07.2016 - 06.2017
- Performed IQ, OQ, PQ for various pharmaceutical clients in the Czech Republic, Slovakia and Russia
- Composed qualification report for the clients based on measured data
Education
Ph.D. - Chemistry And Material Science
University of Chemical Technology
Prague, Czech Republic 09.2013 - 06.2018
Master of Science - Chemistry And Material Science
University of Chemical Technology
Prague, Czech Republic 09.2008 - 06.2013
Skills
Project Management
Construction Management
Cross-functional Coordination
Quality Assurance
Commissioning, Installation, Operational and Process Validation
Change Controls and CAPA
GxP Knowledge
Timeline
Project Manager
Optima Pharma Containment GmbH
02.2024 - Current
Senior Consultant
Deloitte Advisory
01.2023 - 01.2024
Consultant
Novartis
03.2020 - 12.2022
GMP & Biorisk Specialist
Praha Vaccines
10.2017 - 03.2020
CQV Engineer
Lab&Pharma
07.2016 - 06.2017
Ph.D. - Chemistry And Material Science
University of Chemical Technology
09.2013 - 06.2018
Master of Science - Chemistry And Material Science
University of Chemical Technology
09.2008 - 06.2013
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