Norhan Belhaj

Quality Assurance-oriented Molecular Biologist with hands-on GMP experience in biologics within a regulated pharmaceutical environment at Merck Biopharma. Experienced in deviation and CAPA management, audit readiness (FDA), and data integrity (ALCOA+). Proven ability to ensure compliance, maintain inspection readiness, and collaborate across QA, production, and technical teams.

Biology Research Associate – QC Potency Bioassay (GMP Environment) at Merck Biopharma, RBM S.p.A (2025-02 – Present)

Performed GMP-compliant in-vitro potency assays for recombinant biologics within a regulated QC laboratory.

• Performed GMP-compliant in-vitro potency assays for recombinant biologics within a regulated QC laboratory
• Actively contributed to deviation investigations and CAPA management, ensuring GMP compliance and timely resolution
• Supported internal and regulatory audits (FDA readiness), maintaining inspection preparedness
• Reviewed GMP documentation and ensured data integrity (ALCOA+) within validated systems (LIMS, Discoverant)
• Managed batch-related documentation and logbooks, ensuring traceability and compliance
• Oversaw sample lifecycle management in accordance with GMP requirements
• Collaborated cross-functionally with QA, Production, and IT teams in a regulated environment

Research Fellow – Molecular Biology & Biosensor Development (Industry Collaboration) at Università Vita-Salute San Raffaele & DG for Life (2023-06 – 2025-01)

Developed molecular biosensors for pathogen detection within an industry-driven research collaboration.

• Developed molecular biosensors for pathogen detection within an industry-driven research collaboration
• Contributed to the development of a patent-related biosensing technology for sensitive antigen detection
• Interfaced with private sector partners, supporting translation from research to industrial application
• Designed and executed experimental workflows ensuring data reliability, reproducibility, and structured reporting
• Managed experimental documentation and data organization, ensuring traceability and methodological rigor

Research Fellow – Structural Biology & Protein Production at Polytechnic University of Marche (MaSBiC) (2022-05 – 2022-10)

Conducted recombinant protein production and biochemical validation in a high-throughput research facility.

• Conducted recombinant protein production and biochemical validation in a high-throughput research facility
• Ensured accurate documentation and traceability of experimental activities
• Performed analytical assays for protein characterization and enzymatic activity assessment

Academic Tutoring & Laboratory Support (Part-time) at Polytechnic University of Marche (2019-01 – 2022-12)

Supervised laboratory sessions and provided academic support to students.

• Supervised laboratory sessions in Biochemistry and Microbiology, ensuring protocol adherence and safety
• Supported students in experimental activities, strengthening procedural discipline and structured workflows

Master's Degree in Applied and Molecular Biology (LM-6) – Polytechnic University of Marche

Bachelor's Degree in Biological Sciences (L-13) – Polytechnic University of Marche

Licensed Biologist – Italy