31.03.2026 aktualisiert

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Experienced CMC, PD & ADQC Scientist | Expert in Small Molecules, Biologics, mRNA Therapies, Vaccine

Düsseldorf, Deutschland
Weltweit
PhD in Cell and Molecular Biology
Düsseldorf, Deutschland
Weltweit
PhD in Cell and Molecular Biology

Profilanlagen

CV_Mohamad_Toutounji.pdf

Über mich

Senior Consultant in CQV, GMP QA, QC method development, and CMC strategy across biologics, ADCs, mRNA and ATMPs. Skilled in IQ/OQ/PQ, FAT/SAT, URS, CSV, cleaning validation, and tech transfer with expertise in SUS, UF/DF, isolators, and multi‑modality analytics.

Skills

ChromatographieAnalytische ChemieData AnalysisZellkulturenAntikörperMonoklonale AntikörperMolekulares KlonenBiochemieMolekularbiologieSignaltransduktionBiopharmazeutikaBioreaktorenBusiness Process MappingProzessoptimierungDurchflusszytometrieVersuchsplanungDrug DiscoveryEnzymeFmeaTransfektionImmunisierungLIMSMassenspektrometerMolekular- und ZellbiologieMesssystemeMinitabMrnaSpektrometerProzessleittechnikProzessentwicklungProteinreinigungQualitätsmanagementRegulatorischen AnforderungenSoftware-ToolsChromeleonRisikoanalyseSAP ApplicationsJMP (Statistical Software)CRISPRProteinQualitätskontrolleFertigungsprozesseDatenmanagementSignaltechnikGenotypisierungTierschutz
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.
 

Sprachen

ArabischMutterspracheDeutschverhandlungssicherEnglischverhandlungssicher

Projekthistorie

Validation & Qualification Manager

GE Healthcare

Pharma und Medizintechnik

>10.000 Mitarbeiter

  1. Led full validation and Qualification lifecycle (analytical, equipment, process) for radiopharmaceutical site in alignment with ICH Q2(R1), ICH Q8–Q10, EU GMP Annex 15 and 21 CFR 211.
  2. Directed equipment qualification and analytical method validation (HPLC-UV, UV/VIS) with ALCOA+ data integrity, achieving 100% on-time handover and traceability matrix completion.
  3. Implemented risk-based FMEA strategy that reduced qualification timelines by 35% and eliminated rework.
  4. Led deviation investigations and CAPA implementation, ensuring root-cause elimination and continuous improvement.
  5. Mentored QC/validation team and served as validation project manager coordinating QA/QC/RA/Engineering.

Preclinical Scientist - TCR-T Cell Therapy

T-Knife

Pharma und Medizintechnik

50-250 Mitarbeiter

  1. Ensured GMP/GLP-compliant documentation and data traceability for CTA submission, delivering inspection-ready protocols and reports.
  2. Designed, executed, and monitored preclinical studies; authored SOPs and work instructions while supervising technicians.
  3. Resolved technical issues with compliance focus and presented data to R&D and cross-functional teams.

GMP & Regulatory Affairs Trainer

alfatraining

Pharma und Medizintechnik

50-250 Mitarbeiter

  1. Developed and delivered training programs on ICH Q9, ICH Q10, QbD, analytical method validation, and Annex 1/15 requirements for 50+ pharmaceutical professionals.
  2. Created interactive workshops on global regulatory strategies and post-approval changes.

AS&T Technical Expert | BioNTech IMFS

BioNTech

Pharma und Medizintechnik

1000-5000 Mitarbeiter

  1. Developed and validated 7 critical analytical methods for mRNA DS/DP (HPLC, ddPCR, cGE) per ICH Q2 and regulatory guidelines.
  2. Coordinated analytical lifecycle and tech transfer with 3 external CDMOs; resolved method discrepancies and contributed to Module 3 dossier updates.
  3. Supported CMC activities and maintained validated state across sites.

Senior Scientist, mRNA Manufacturing Platform | Lonza | September 2023 – April 2024 | Geleen, The Netherlands

Lonza

Pharma und Medizintechnik

1000-5000 Mitarbeiter

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.

Project Leader, CMC & Process Analytics | GE Healthcare | September 2022 – August 2023 | Brunswick, Germany

GE Healthcare

Pharma und Medizintechnik

1000-5000 Mitarbeiter

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.

Protein Biochemist, Senior Scientist | Sanofi | August 2021 – August 2022 | Amsterdam, The Netherlands

Sanofi

Pharma und Medizintechnik

1000-5000 Mitarbeiter

Modalities: Cell Therapy (CAR-T, CAR-NK) and Biologics (infectious diseases)
Developed and implemented a novel HPLC method for quantifying CAR-T cell populations, leading to a 20% reduction in analysis time and enabling faster characterization of cell therapy products.
Designed and executed experiments to gain deep understanding of upstream processes for CAR-T cell therapy, resulting in the identification of a critical parameter that improved cell expansion efficiency by 15%.
Validated cleaning procedures for the CAR-T cell manufacturing process, mitigating risk of product contamination and ensuring consistent product quality.
Utilized the TACT approach to identify critical process parameters (CPPs) for optimal production of a new soluble TCR as biologic, leading to a more robust and efficient manufacturing process.
Established acceptance criteria and critical quality attributes (CQAs) based on product design and risk assessments, ensuring product safety and efficacy.
Leveraged expertise in T cell biology and CAR-T approaches to significantly contribute to different immunotherapy projects. Prepared detailed protocols, analyzed complex datasets, and authored scientific reports used for CTD preparation, facilitating a successful regulatory submission.
Led the preparation of Common Technical Document (CTD) sections for clinical studies for CAR-T cell therapies, demonstrating strong skills in data interpretation, scientific writing, and preclinical documentation. Utilized Benchling for efficient data management and collaborated effectively with cross-functional teams to ensure comprehensive and high-quality submissions.

CMC Lead | Molgenium | January 2019 – July 2021 | Düsseldorf, Germany

Molgenium

Pharma und Medizintechnik

< 10 Mitarbeiter

Modalities: ATMP (Adipose-derived stem cell therapy, delivery platform of genetic materials)
1. Successfully managed outsourced CMC development activities for CMOs, ensuring strict adherence to GMP regulations for biopharmaceutical production intended for human use.
Delivered a 0% delay rate in supplying toxicology and clinical trial materials that met all internal and regulatory quality expectations, facilitating timely clinical trial initiation.
Led projects to achieve on-time and within-budget completion, demonstrating strong project management skills and a focus on efficiency.
Reviewed and approved technical documents for CMC activities, managing stability data tracking for successful shelf-life extension of products.
Effectively led internal CMC team meetings, managing scheduling, agendas, and minutes preparation to ensure clear communication and project progress.
Identified, assessed, and mitigated quality, operational, and organizational risks within the CMC development process, proactively managing potential issues and ensuring project success.
Prepared comprehensive CMC sections for regulatory filings and addressed related feedback, contributing to successful regulatory approvals.
Led the CMC development and optimization of CAR-T cell manufacturing processes, achieving significant improvements in yield high level of purity and functionality of the final cell therapy product for clinical trials.
Managed the preparation and submission of CMC documentation for IND/CTA applications for CAR-T cell therapies, ensuring compliance with all regulatory requirements for ATMPs.
Developed and implemented a comprehensive quality control strategy for CAR-T cell products, including establishing robust release criteria and stability testing protocols to support critical clinical phase studies.

Zertifikate

GMP-Manager

TÜV

2019

Projektmanagement

TÜV

2019

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