Radostin Dimitrov
Senior Biotech Engineer | QC & GMP Complience | Qualified Person
Sofia
Summary
Highly skilled biotechnology Engineer with 10+ years of expertise in biopharmaceutical manufacturing, specializing in Quality Control (QC) and GMP compliance. Adept at leading innovative QC method development, process optimization, and continuous improvement initiatives in fast-paced, regulated environments. Proven track record of enhancing product quality, ensuring regulatory compliance, and driving operational excellence.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
4
4
Languages
Work History
QC Compliance Manager
CONCEPT HEIDELBERG GmbH
03.2020
ECA - FDA Compliance in Analytical Laboratories
CONCEPT HEIDELBERG GmbH
10.2017
ISO 9001:2015 for internal audits
Lloyd's Register
02.2016
Head of Research and Development Unit
BB-NCIPD
09.2022 - Current
- Leading Laboratory Operations: Supervise and coordinate a laboratory team to ensure timely completion of scheduled tasks, prioritization of workload, and optimization of operational efficiency.
- Research & Method Development: Head a research group as part of international projects focused on developing innovative methods for evaluating vaccine potency.
- Advancing Ethical Testing Methods: Design and implement novel methodologies, including humane approaches to animal testing, in strict adherence to the 3Rs principles (Replacement, Reduction, Refinement).
- International Collaboration: Engage with global research teams in the development of next-generation vaccines, fostering scientific partnerships and knowledge exchange.
- Reference Standards & Regulatory Compliance: Assess international and in-house reference standards using approved methods and prepare comprehensive regulatory documentation in alignment with national and international guidelines.
- Handling of Hazardous Substances: Manage and conduct research involving highly toxic biological agents, including bacterial toxins and venoms, ensuring strict biosafety and compliance with regulatory protocols.
- Stability & Quality Control Analysis: Evaluate stability studies of bacterial vaccines and intermediate products, providing critical statistical data to assess and maintain product quality.
- Mentorship & Cross-Department Collaboration: Train and mentor team members in specialized procedures and methodologies, while offering expertise and support to Quality Assurance and Production teams on specific challenges.
Quality Control Specialist
BB-NCIPD
03.2014 - 09.2022
- Product Testing: Planned and conducted various chemical and biological tests to ensure product compliance with GMP, Phr. Eu. guidelines, and WHO requirements.
- Laboratory Coordination: Oversaw and coordinated laboratory activities, ensuring the timely completion of necessary analyses by scheduling routine checks and prioritizing tasks based on workload.
- SOP Development & Regulatory Compliance: Developed, revised, and implemented SOPs to uphold best practices in quality control and maintain regulatory compliance.
- Method Validation & Instrumentation: Validated analytical methods and laboratory instrumentation to ensure precision, accuracy, and reliability in test results.
- Technical Support & Training: Provided technical guidance and support to production teams regarding procedures, fostering compliance and operational efficiency.
- GMP Audit: Participated in GMP audits conducted by regulatory bodies such as the Bulgarian Drug Agency, WHO, and other national health authorities (including Turkey, Russia, South Korea, and Brazil).
Research Assistant (Master Thesis)
Universitat Politècnica de Catalunya
05.2013 - 10.2013
- Innovative Coating Development: Developed a novel protective coating for silicone catheters to reduce bacterial biofilm formation, addressing a critical healthcare challenge in medical device-associated infections.
- Advanced Material Characterization: Employed fluorescent microscopy, FTIR spectroscopy, and other analytical techniques to assess coating properties and bacterial interactions.
- Microbial Adhesion Studies: Investigated bacterial adhesion mechanisms by working with diverse bacterial strains and optimizing seeding techniques for experimental accuracy.
- Scientific Writing & Research Communication: Authored scientific reports and a master’s thesis, demonstrating strong technical writing and analytical skills.
- Published Research Contribution: Published a peer-reviewed scientific article, contributing to advancements in biomaterials and infection control research.
- https://gbmi.upc.edu/en
Education
Master of Science - Biotechnology, Biochemistry of Secondary Metabolism, Probiotics, Bioinformatics, Molecular Basis of Pharmaceutical Biotechnology, Biosensors, Genetic Engineering, HPLC Techniques, Catalysis, Renewable Energy Sources
University of Chemical Technology And Metallurgy
Sofia 05.2012 - 12.2013
Bachelor of Science - Biotechnology, Inorganic Chemistry, Analytical Chemistry, Organic Chemistry, Biochemistry, Bioorganic Chemistry, Microbiology, Molecular Biology, Biocatalysis, Bioconversion, Immunology, Pharmaceutical Biotechnology, Ecology
University of Chemical Technology And Metallurgy
Sofia 09.2008 - 06.2012
Qualified Person (QP) certification - Medical Microbiology, Medical Biochemistry, Human Physiology, Pharmacognosy, Pharmacology and Toxicology, Technology of Dosage Forms and Biopharmaceutics
Medical University of Sofia
03.2024 - 12.2024
Skills
- Regulatory Compliance & GMP Knowledge
- Method Development & Validation
- Document Review & Regulatory Writing
- Quality Control & Audits
- Data Analysis & Statistical Interpretation
- Scientific & Technical Writing
- Cross-Functional Collaboration & Leadership
- Analytical Thinking & Decision-Making
- Software and computer systems
Certification
Qualified Person (QP), Medical University of Sofia
Publications
Building an Antifouling Zwitterionic Coating on Urinary Catheters Using an Enzymatically-Triggered Bottom-Up Approach
Applied Materials & Interfaces, American Chemical Society – June 23, 2014
http://pubs.acs.org/doi/abs/10.1021/am501961b
Additional Information
B
References
References available upon request
Timeline
Qualified Person (QP), Medical University of Sofia
02-2025
Qualified Person (QP) certification - Medical Microbiology, Medical Biochemistry, Human Physiology, Pharmacognosy, Pharmacology and Toxicology, Technology of Dosage Forms and Biopharmaceutics
Medical University of Sofia
03.2024 - 12.2024
Certified Quality Control Manager, CONCEPT HEIDELBERG, GmbH
09-2022
Head of Research and Development Unit
BB-NCIPD
09.2022 - Current
QC Compliance Manager
CONCEPT HEIDELBERG GmbH
03.2020
ECA - FDA Compliance in Analytical Laboratories
CONCEPT HEIDELBERG GmbH
10.2017
ISO 9001:2015 for internal audits, Lloyd's Register
02-2016
ISO 9001:2015 for internal audits
Lloyd's Register
02.2016
Quality Control Specialist
BB-NCIPD
03.2014 - 09.2022
Research Assistant (Master Thesis)
Universitat Politècnica de Catalunya
05.2013 - 10.2013
Master of Science - Biotechnology, Biochemistry of Secondary Metabolism, Probiotics, Bioinformatics, Molecular Basis of Pharmaceutical Biotechnology, Biosensors, Genetic Engineering, HPLC Techniques, Catalysis, Renewable Energy Sources
University of Chemical Technology And Metallurgy
05.2012 - 12.2013
Bachelor of Science - Biotechnology, Inorganic Chemistry, Analytical Chemistry, Organic Chemistry, Biochemistry, Bioorganic Chemistry, Microbiology, Molecular Biology, Biocatalysis, Bioconversion, Immunology, Pharmaceutical Biotechnology, Ecology
University of Chemical Technology And Metallurgy
09.2008 - 06.2012
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