27.02.2025 aktualisiert
100 % verfügbar
Experienced CMC, PD & ADQC Scientist | Expert in Small Molecules, Biologics, mRNA Therapies, Vaccine
Düsseldorf, Deutschland
Weltweit
PhD in Cell and Molecular BiologySkills
QualitätskontrolleQualitätssicherungGMPProzessanalytikerTrendanalysenpharmazeutische industrieZellbiologieBiochemiegentherapieImpfstoffe
Key Skills & Expertise
Process Development & Optimization:
Master Plan Development: Proven experience in creating validation and transfer master plans for cell culture, bioreactors, and protein purification.
Risk Assessment: Conducted process FMEAs to identify and mitigate risks associated with the manufacturing process.
CQAs & CPPs: Expertise in identifying critical quality attributes (CQAs) and critical process parameters (CPPs) through FMEA and Design of Experiments (DoE) studies.
Specific Studies: Performed and documented studies including: SDM Qualification, Resin Lifetime Studies, LIVCA Studies, Viral Clearance Studies, Process Mapping, Performance Qualification (PQ) Studies, and DoE Studies, adhering to relevant regulatory requirements (ICH Q5a/Q6b, pharmacopeias).
In-process Controls: Extensive experience in monitoring product quality throughout the manufacturing process, including conducting stability studies and comparability studies to ensure product consistency.
Software Proficiency: Adept at utilizing JMP, Minitab, and other software tools for data analysis and process optimization.
Analytical Expertise:
Diverse Techniques: Skilled in a wide range of analytical techniques such as UV/VIS, Next-Generation Sequencing (NGS), Flow Cytometry, protein analysis, and particle characterization.
Quality Control: Experienced in performing titrations, mass spectrometry, and various forms of chromatography (TLC, HPLC, GC, etc.) for quality control purposes.
Software: Proficient in LIMS, SAP, Kneat, Empower, and Chromeleon software for data management and analysis.
Molecular Biology & Gene Delivery:
Genetic Tools: Expertise in utilizing gene delivery systems like AAV, CRISPR Cas9, MEGATal, and siRNA.
Techniques: Proficient in molecular cloning, in silico analysis, dd-PCR, and organoid transfection for drug discovery and investigating cellular/molecular mechanisms.
Cell Biology & Biochemistry:
Post-translational Modifications: Analysis and characterization of post-translational modifications on proteins.
Enzyme Activity: Measurement and optimization of enzyme activity.
Lipid Signaling: Expertise in investigating lipid signaling pathways.
Antibody Development: Skilled in epitope mapping and antibody engineering.
Animal Handling (FELASA C Certified):
Transgenic Animals: Skilled in handling, breeding, and genotyping of transgenic animals.
Process Development & Optimization:
Master Plan Development: Proven experience in creating validation and transfer master plans for cell culture, bioreactors, and protein purification.
Risk Assessment: Conducted process FMEAs to identify and mitigate risks associated with the manufacturing process.
CQAs & CPPs: Expertise in identifying critical quality attributes (CQAs) and critical process parameters (CPPs) through FMEA and Design of Experiments (DoE) studies.
Specific Studies: Performed and documented studies including: SDM Qualification, Resin Lifetime Studies, LIVCA Studies, Viral Clearance Studies, Process Mapping, Performance Qualification (PQ) Studies, and DoE Studies, adhering to relevant regulatory requirements (ICH Q5a/Q6b, pharmacopeias).
In-process Controls: Extensive experience in monitoring product quality throughout the manufacturing process, including conducting stability studies and comparability studies to ensure product consistency.
Software Proficiency: Adept at utilizing JMP, Minitab, and other software tools for data analysis and process optimization.
Analytical Expertise:
Diverse Techniques: Skilled in a wide range of analytical techniques such as UV/VIS, Next-Generation Sequencing (NGS), Flow Cytometry, protein analysis, and particle characterization.
Quality Control: Experienced in performing titrations, mass spectrometry, and various forms of chromatography (TLC, HPLC, GC, etc.) for quality control purposes.
Software: Proficient in LIMS, SAP, Kneat, Empower, and Chromeleon software for data management and analysis.
Molecular Biology & Gene Delivery:
Genetic Tools: Expertise in utilizing gene delivery systems like AAV, CRISPR Cas9, MEGATal, and siRNA.
Techniques: Proficient in molecular cloning, in silico analysis, dd-PCR, and organoid transfection for drug discovery and investigating cellular/molecular mechanisms.
Cell Biology & Biochemistry:
Post-translational Modifications: Analysis and characterization of post-translational modifications on proteins.
Enzyme Activity: Measurement and optimization of enzyme activity.
Lipid Signaling: Expertise in investigating lipid signaling pathways.
Antibody Development: Skilled in epitope mapping and antibody engineering.
Animal Handling (FELASA C Certified):
Transgenic Animals: Skilled in handling, breeding, and genotyping of transgenic animals.
Sprachen
ArabischMutterspracheDeutschverhandlungssicherEnglischverhandlungssicher
Projekthistorie
Modalities: Cell Therapy (CAR-T) and mRNA Vaccines (infectious diseases)
Developed and implemented 5 new analytical methods for mRNA vaccine characterization, enabling faster process optimization and reducing time-to-market by 10%.
Established a comprehensive monitoring program to support process characterization of mRNA vaccines, leading to a 15% improvement in production yield.
Oversaw the validation and management of 20+ analytical methods used throughout the mRNA vaccine lifecycle, ensuring data integrity and compliance with regulatory requirements.
Bridged the gap between internal and external standards for mRNA vaccine analysis, identifying and addressing discrepancies in 3 critical assays, leading to a more robust data package for regulatory submissions.
Led the design and execution of 2 research studies for CTA submissions related to CAR-T therapies, ensuring data traceability and adherence to laboratory ethics and SOPs.
Developed and implemented 5 new analytical methods for mRNA vaccine characterization, enabling faster process optimization and reducing time-to-market by 10%.
Established a comprehensive monitoring program to support process characterization of mRNA vaccines, leading to a 15% improvement in production yield.
Oversaw the validation and management of 20+ analytical methods used throughout the mRNA vaccine lifecycle, ensuring data integrity and compliance with regulatory requirements.
Bridged the gap between internal and external standards for mRNA vaccine analysis, identifying and addressing discrepancies in 3 critical assays, leading to a more robust data package for regulatory submissions.
Led the design and execution of 2 research studies for CTA submissions related to CAR-T therapies, ensuring data traceability and adherence to laboratory ethics and SOPs.
Modalities: Biologics (ADCs), Gene Therapy (CRISPR) and mRNA Vaccines (platform approach)
Led the implementation of process characterization and validation strategies for the mRNA manufacturing platform, resulting in a 20% reduction in validation cycle time and enabling faster product development.
Championed the technology transfer process for the mRNA manufacturing platform, ensuring a smooth and efficient transition to production for a new mRNA based therapy product.
Developed and established clear specifications and acceptance criteria for all stages of the CRISPR based gene therapy manufacturing process, ensuring product quality and consistency for beta thalassemia therapy platform.
Ensured process validation documentation aligned with all relevant regulatory requirements, including ICH Q1A (Stability Testing) and ICH Q5E (Quality by Design), facilitating a successful regulatory submission for a soluble TCR product.
Prepared detailed technical reports, including batch summary reports and comprehensive process validation reports, adhering to FDA 21 CFR Part 211 and EMA guidelines.
Led the implementation of process characterization and validation strategies for the mRNA manufacturing platform, resulting in a 20% reduction in validation cycle time and enabling faster product development.
Championed the technology transfer process for the mRNA manufacturing platform, ensuring a smooth and efficient transition to production for a new mRNA based therapy product.
Developed and established clear specifications and acceptance criteria for all stages of the CRISPR based gene therapy manufacturing process, ensuring product quality and consistency for beta thalassemia therapy platform.
Ensured process validation documentation aligned with all relevant regulatory requirements, including ICH Q1A (Stability Testing) and ICH Q5E (Quality by Design), facilitating a successful regulatory submission for a soluble TCR product.
Prepared detailed technical reports, including batch summary reports and comprehensive process validation reports, adhering to FDA 21 CFR Part 211 and EMA guidelines.
Modalities: Small molecules (Radiopharmaceuticals)
Led the development and validation of 7 new analytical assays for radiopharmaceutical products using HPLC-UV and UV-VIS techniques, ensuring compliance with GMP regulations. This facilitated a 40% improvement in process efficiency for radiopharmaceutical production.
Developed and qualified 8 reference materials to support analytical testing, reducing result variability by 50% and ensuring the accuracy and consistency of data used for drug development and regulatory submissions.
Successfully managed 2 drug product development projects in collaboration with cross-functional teams, driving projects towards established timelines and achieving all quality targets. Ensured development activities adhered to EP, USP, ICH, and EMA/FDA guidelines.
Led the definition of drug product specifications for 4 radiopharmaceuticals, guaranteeing product quality and meeting all regulatory requirements. Played a key role in establishing the safety profile of these products.
Effectively communicated scientific data within Science and R&D departments through presentations and reports, fostering collaboration and knowledge sharing across departments.
Provided scientific guidance and mentorship to a team of 6 technicians, supporting their professional development and ensuring high-quality analytical outputs.
Led the development and validation of 7 new analytical assays for radiopharmaceutical products using HPLC-UV and UV-VIS techniques, ensuring compliance with GMP regulations. This facilitated a 40% improvement in process efficiency for radiopharmaceutical production.
Developed and qualified 8 reference materials to support analytical testing, reducing result variability by 50% and ensuring the accuracy and consistency of data used for drug development and regulatory submissions.
Successfully managed 2 drug product development projects in collaboration with cross-functional teams, driving projects towards established timelines and achieving all quality targets. Ensured development activities adhered to EP, USP, ICH, and EMA/FDA guidelines.
Led the definition of drug product specifications for 4 radiopharmaceuticals, guaranteeing product quality and meeting all regulatory requirements. Played a key role in establishing the safety profile of these products.
Effectively communicated scientific data within Science and R&D departments through presentations and reports, fostering collaboration and knowledge sharing across departments.
Provided scientific guidance and mentorship to a team of 6 technicians, supporting their professional development and ensuring high-quality analytical outputs.
Zertifikate
GMP-Manager
TÜV2019
Projektmanagement
TÜV2019