Rachid Marhaba - Associate Director – Head Lab Support Functions
Experience
Associate Director – Head Lab Support Functions
IQVIA Laboratories
- Head of department overseeing laboratory operations, ensuring efficient, compliant, and inspection-ready processes across BSL-2 and BSL-3 areas
- EHS site lead and biosafety officer for BSL-2 and BSL-3 laboratories (conventional and GMO), ensuring adherence to biosafety, biosecurity, and regulatory requirements
- Primary point of contact with local authorities, responsible for regulatory submissions and approvals for BSL-2/BSL-3 operations, including GMO registration (S2/S3)
- Risk management activities, including risk assessments, mitigation strategies, and continuous monitoring to ensure safe and compliant operations
- Successfully led the organization through ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health & Safety) certifications, embedding sustainable and safe operational practices across the site
- Lifecycle management of laboratory equipment and facilities, including strategic planning, acquisition, qualification, validation, and maintenance oversight
Senior Scientist – Scientific & Technical Excellence
GSK Vaccines
- Led and oversaw assay development, qualification, and validation programs to demonstrate vaccine immunogenicity in alignment with regulatory and clinical requirements
- Reviewed, approved, and released comprehensive assay validation packages for regulatory submissions to FDA, EMA, and other global health authorities
- Directed assay transfer and outsourcing activities, including vendor selection, technical transfer oversight, and CRO qualification to ensure compliance and operational excellence
- Defined assay strategies for clinical evidence generation, ensuring robust analytical approaches throughout vaccine development phases
- Supported the evaluation and integration of novel technologies for advancing clinical readout development and enhancing analytical capabilities
Head of Assay Development – Bioanalytical Development
Novartis Vaccines & Diagnostics
- Led a team of scientists responsible for developing analytical assays to assess vaccine immunogenicity across multiple platforms and development stages
- Oversaw assay qualification and validation in alignment with international regulatory guidelines (ICH, FDA, EMA) to ensure robustness, reproducibility, and compliance
- Collaborated with and supported the QC department in Italy for the release of commercial vaccine batches, ensuring analytical readiness and regulatory alignment
- Directed assay transfer and outsourcing activities, including technical transfer oversight, CRO selection, and performance monitoring to ensure high-quality data delivery
- Managed budget planning and resource allocation, optimizing operational efficiency and project delivery timelines
Laboratory Head – Clinical Serology
Novartis Vaccines
- Led a team responsible for analytical testing of Phase I–III clinical trial samples, ensuring high-quality data generation in support of clinical development programs
- Managed assay transfers from research into GxP clinical testing, including method implementation, qualification/validation, and readiness for regulated environments
- Oversaw outsourcing and vendor management activities, including CRO auditing, qualification, performance oversight, and issue resolution to ensure compliance and data integrity
- Held full budget ownership, including planning, forecasting, and resource allocation to support operational efficiency and strategic priorities
Group Leader – Cancer Immunology
German Cancer Research Center (DKFZ)
- Investigated the role of CD44 variant isoforms in T-lymphocyte activation, maturation, and autoimmune disease mechanisms
- Characterized the involvement of CD44 variant isoforms in tumor progression and immune surveillance pathways
- Studied the functional impact of IL-1α and IL-1β on tumor growth and inflammation-driven oncogenic processes
- Supervised and mentored a multidisciplinary team of PhD students and laboratory technicians, providing scientific guidance and operational oversight
Post-Doctoral Fellow – Cancer Immunology
German Cancer Research Center (DKFZ)
- Investigated the role of CD44 variant isoforms in T-lymphocyte activation, maturation, and autoimmune disease mechanisms
Industry Experience
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Experienced in Biotechnology and Pharmaceutical.
Business Area Experience
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Experienced in Research and Development, Quality Assurance, and Operations.
Summary
Scientific leader with 18 years of experience in highly regulated pharmaceutical environment. Proven track record in building high-performing teams, implementing and optimizing EHS management systems, and driving safety, compliance, and operational excellence across complex, automated laboratory settings. Strong expertise in risk assessments, regulatory compliance, incident prevention (including SIF-focused programs), and sustainable site strategies. Recognized expert in ISO 14001/45001 management systems, and sustainability initiatives.
Skills
- Risk Management & Safety Culture
- Iso 14001/45001
- Incident Investigation, Emergency Response
- Regulatory Submissions & Regulatory Inspections Readiness
- Chemical And Waste Management
- Strong Governance Of Quality Systems, Including Oversight Of Change Controls, Deviation Management, And Capa Implementation.
- Registered Project Leader Under §15 Gentsv (Genetic Engineering Safety Ordinance).
- Certified Safety Professional (Fachkraft Für Arbeitssicherheit)
- Certified Hazardous Substances Management
- Budget Management And Resource Planning.
Languages
Education
University of Nice
PhD · Life Sciences, Immunology · Nice, France
University of Nice
Postgraduate · Pharmacology, Cellular and Molecular Biology · Nice, France
University of Nice
Master of Sciences · Biochemistry · Nice, France
Certifications & licenses
Certified Hazardous Substances Management
Certified Safety Professional (Fachkraft für Arbeitssicherheit)
Registered Project Leader under §15 GenTSV (Genetic Engineering Safety Ordinance)
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Experience
Global Experience
Expertise
Qualifications
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