Emmanuelle Naud Email & Phone Number

London Area, United Kingdom

Managing projects and initiatives to facilitate the augmenting of current global scale practices with a mesh of robust regional vaccine manufacturing facilities capable of production during both pandemic and routine eras, specifically catered to each region’s health outcome needs.

Vienna, Austria/Livingston, Scotland

• Provide direct leadership for day-to-day technical activities for commercial manufacturing. Evaluate and implement changes required to maintain state-of-the-art compliant processes in alignment with internal and external stakeholders. • Maintaining oversight on CMOs’ quality systems to ensure highest quality standards, supporting deviation investigation, validation projects and performing site audits.• Overall technical project management relating to the commercial manufacturing of vaccine – i.e., process improvement, capacity increasing, new product introduction.• Monitoring of manufacturing processes and evaluation of process data at external CMO (aseptic fill, lyophilization, packaging)

Livingston, Scotland, United Kingdom

• Leading process validation strategy for implementation of a new commercial scale COVID Vaccine• Supervising major and critical quality issues such as investigations, risk assessment, changes and CAPA implementation.• Review and approval of technical and quality documentation, writing and review of CMC sections (clinical and commercia

Vienna, Austria

• Planning, implementation and management of complex microbiological and viral projects at CDMOs including technical transfer, scale-up, process validation and GMP manufacturing.• Leading CMO selection and qualification by performing technical review, supplier audit and regular sites visits• Ensuring monitoring and quality oversight of GMP-compliant manufacturing processes for Drug Substance, Drug Product and adjuvant including fill & finish and coordination of international multidisciplinary teams and external partners.• Supervising major and critical quality issues such as investigations, risk assessment and CAPA implementation.• Review and approval of technical and quality documentation prior to manufacturing operation and release by QP.• Compilation of CMC section for submission to competent authorities for clinical trial.• Implementation, management and improvement of various systems and processes (Storage and control of critical material, sample management, labelling and secondary packaging review and approval)

Livingston, Scotland, United Kingdom

• Cross functional team coordination of production related activities (QC, SCM and Engineering).• Planning and scheduling of commercial production and support activities.• Improvement of processes and systems to increase compliance level.

Livingston, Scotland, United Kingdom

• Assay development and validation (PRNT, Plaque assay)• Process development, scale-up and GMP commercial production.• Involved in design of the commercial facility and preparation for FDA pre-approval inspection

Montreal, Quebec, Canada

• Development of an adenovirus library for protein expressions and ligase-free cloning system• Gene cloning, viral amplification and purification of Adenovirus• Optimized and maintained culture of cell lines for adenovirus generation.

Certificate, Management

Master, Biochemistry

Hopital Ste-Justine

Bachelor, Biochemistry