Emmanuelle Naud Email and Phone Number
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Over 20 years of experience in leading multiple projects, process validation, technology transfer, maintaining quality oversight of GMP manufacturing of sterile biologic products, aseptic filling, lyophilization and secondary packaging. A solid understanding of virology, regulatory and cGMP requirements (FDA and EMA), biochemistry, cellular biology. Excellent communication, interpersonal, organizational, planning and time management skills. Demonstrated ability to work both independently and lead multidisciplinary international team by building solid relationships and strong resilience in everchanging environment. Ability to effectively multi-task with competing priorities, distribute workload and find innovative ways to solve problems.
Regionalized Vaccine Manufacturing Collaborative
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Senior Project ManagerRegionalized Vaccine Manufacturing Collaborative Aug 2024 - PresentLondon Area, United KingdomManaging 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.
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Senior External Manufacturing Manager, Industrial OperationValneva Oct 2022 - Aug 2024Vienna, 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) -
Principal Scientist - Technical Operation At Valneva ScotlandValneva Jan 2021 - Oct 2022Livingston, 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
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External Manufacturing Senior Project ManagerValneva Austria Sep 2008 - Dec 2020Vienna, 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)
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Production Support ManagerIntercell Biomedical Ltd Sep 2007 - Sep 2008Livingston, 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.
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ScientistIntercell Biomedical Jan 2004 - Aug 2007Livingston, 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
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Research AssistantQbiogene Oct 2002 - Dec 2003Montreal, 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.
Emmanuelle Naud Skills
Emmanuelle Naud Education Details
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West Lothian College, ScotlandManagement -
Biochemistry -
Biochemistry
Frequently Asked Questions about Emmanuelle Naud
What company does Emmanuelle Naud work for?
Emmanuelle Naud works for Regionalized Vaccine Manufacturing Collaborative
What is Emmanuelle Naud's role at the current company?
Emmanuelle Naud's current role is Senior Project Manager, Regionalized Vaccine Manufacturing Collaborative.
What is Emmanuelle Naud's email address?
Emmanuelle Naud's email address is en****@****ell.com
What is Emmanuelle Naud's direct phone number?
Emmanuelle Naud's direct phone number is (301)-556*****
What schools did Emmanuelle Naud attend?
Emmanuelle Naud attended West Lothian College, Scotland, Uqam | Université Du Québec À Montréal, Uqam | Université Du Québec À Montréal.
What skills is Emmanuelle Naud known for?
Emmanuelle Naud has skills like Vaccines, Gmp, Biotechnology, Biopharmaceuticals, Validation, Technology Transfer, Glp, Life Sciences, Capa, Molecular Biology, Pharmaceutical Industry, Quality System.
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Emmanuelle Naud
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Emmanuelle Naud
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