Olène DORIEUX
Project Manager Vaccine at LinKinVax- Claim this Profile
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French Native or bilingual proficiency
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English Professional working proficiency
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German Elementary proficiency
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Bio
Tran Ba Quang Truong
I had the great opportunity to work with Olene on complex CMC dossiers and BLA. She is a smart person who has a lot of scientific curiosity undoubtedly thanks to her strong scientific background. She is a fast learner and is able to master topics she has never been facing with before. Moreover, she is a charming person I appreciated working with.
Tran Ba Quang Truong
I had the great opportunity to work with Olene on complex CMC dossiers and BLA. She is a smart person who has a lot of scientific curiosity undoubtedly thanks to her strong scientific background. She is a fast learner and is able to master topics she has never been facing with before. Moreover, she is a charming person I appreciated working with.
Tran Ba Quang Truong
I had the great opportunity to work with Olene on complex CMC dossiers and BLA. She is a smart person who has a lot of scientific curiosity undoubtedly thanks to her strong scientific background. She is a fast learner and is able to master topics she has never been facing with before. Moreover, she is a charming person I appreciated working with.
Tran Ba Quang Truong
I had the great opportunity to work with Olene on complex CMC dossiers and BLA. She is a smart person who has a lot of scientific curiosity undoubtedly thanks to her strong scientific background. She is a fast learner and is able to master topics she has never been facing with before. Moreover, she is a charming person I appreciated working with.
Credentials
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BULATS
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Experience
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LinKinVax
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France
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Biotechnology Research
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1 - 100 Employee
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Project Manager Vaccine
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Dec 2022 - Present
- Project Management at corporate scale - Transversal program management of early biotechnological vaccine - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Planning management: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Project management for the manufacturing and controls: - New specifications, new… Show more - Project Management at corporate scale - Transversal program management of early biotechnological vaccine - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Planning management: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Project management for the manufacturing and controls: - New specifications, new formulation, MBR, analytical procedures and validation review, site visit - Module 3 preparation and review, regulatory outsourcing selection Show less - Project Management at corporate scale - Transversal program management of early biotechnological vaccine - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Planning management: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Project management for the manufacturing and controls: - New specifications, new… Show more - Project Management at corporate scale - Transversal program management of early biotechnological vaccine - Project meeting organization with cross-functional and multidisciplinary teams (preclinical, CMC, regulatory, clinical, quality), writing of agenda & minutes - Planning management: planning (Microsoft Project software), roadmap, dashboards, reporting on milestones - Project management for the manufacturing and controls: - New specifications, new formulation, MBR, analytical procedures and validation review, site visit - Module 3 preparation and review, regulatory outsourcing selection Show less
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Cellectis
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France
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Biotechnology Research
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200 - 300 Employee
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Senior Regulatory Specialist
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Oct 2020 - Nov 2022
INDs US, CTA EU, gene therapy ATMPs, mRNA, TALEN, rLV Module 3, CMC documentation, Quality documentation INDs US, CTA EU, gene therapy ATMPs, mRNA, TALEN, rLV Module 3, CMC documentation, Quality documentation
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becton and dickinson
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory CMC specialist
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Aug 2019 - Oct 2020
Combination Product Construction of a EU level Module 3 and 2.3 from a manufacturing process US variation. Construction of CMC documentation for manufacturing process variations for OUS countries. Combination Product Construction of a EU level Module 3 and 2.3 from a manufacturing process US variation. Construction of CMC documentation for manufacturing process variations for OUS countries.
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Guerbet
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs CMC - Umanis Consultant
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Nov 2018 - Jul 2019
Authoring: -Q&As to Health Authorities (Vietnam, Turkey, Malaysia, Uruguay) -Gap Analysis and Present/Proposed table of a CMC dossier (32S & 32P), and identification of the variations (EU). -Injection kit dossier (France) Project activity: implementation of the ICHQ3D regulatory strategy -Contribution as Regulatory CMC to multidisciplinary meetings -Authoring CTD sections Authoring: -Q&As to Health Authorities (Vietnam, Turkey, Malaysia, Uruguay) -Gap Analysis and Present/Proposed table of a CMC dossier (32S & 32P), and identification of the variations (EU). -Injection kit dossier (France) Project activity: implementation of the ICHQ3D regulatory strategy -Contribution as Regulatory CMC to multidisciplinary meetings -Authoring CTD sections
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Umanis
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France
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IT Services and IT Consulting
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100 - 200 Employee
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Regulatory Affairs CMC - Consultant for Sanofi Pasteur
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Oct 2016 - Nov 2018
Project leader: EU CTD update -Coordination with other departments and function, team coordination, planning managment -Review of EU CTD sections: Drug Product Module 3 and 2.3 -Authoring CTD sections: Drug Substance and Drug Product Module 3 and 2.3 Authoring: -New vaccine Biologics License Application – FDA: 32A1 Facilities and Equipment (General Overview Flow and Contamination Control), module 23S Quality Overall Summary. -CTD update Europe: Drug Substance Module 3 and… Show more Project leader: EU CTD update -Coordination with other departments and function, team coordination, planning managment -Review of EU CTD sections: Drug Product Module 3 and 2.3 -Authoring CTD sections: Drug Substance and Drug Product Module 3 and 2.3 Authoring: -New vaccine Biologics License Application – FDA: 32A1 Facilities and Equipment (General Overview Flow and Contamination Control), module 23S Quality Overall Summary. -CTD update Europe: Drug Substance Module 3 and 2.3 (32S22 description of Manufacturing Process, 32S23 Control of Materials, 32S25 Process Validation, 32S26 Manufacturing Process Development, 32S42 Analytical Procedures, 32S43 Validation of Analytical Procedures, 32S44 Batch Analysis). -CTD update Europe: 32A2 Adventitious Agents Safety Evaluation, 32R Table A and B, and corresponding module 2 sections. -CMC Variation Europe, type I.B, new validations of the Drug Substance intermediate holding times. -Pre-Qualified Vaccine Annual Reports - WHO (annual stability studies, information on production). -Q&A to Health Authorities: Validation of filled syringe sterilization. -Renewals: Stability studies, certificate of analysis (DS, DP, adjuvants). Team activity: -Training: Vaccine Manufacturing Awareness (15 people). -Redesign of the workrequest forms (between Sanofi Pasteur and Umanis). Show less Project leader: EU CTD update -Coordination with other departments and function, team coordination, planning managment -Review of EU CTD sections: Drug Product Module 3 and 2.3 -Authoring CTD sections: Drug Substance and Drug Product Module 3 and 2.3 Authoring: -New vaccine Biologics License Application – FDA: 32A1 Facilities and Equipment (General Overview Flow and Contamination Control), module 23S Quality Overall Summary. -CTD update Europe: Drug Substance Module 3 and… Show more Project leader: EU CTD update -Coordination with other departments and function, team coordination, planning managment -Review of EU CTD sections: Drug Product Module 3 and 2.3 -Authoring CTD sections: Drug Substance and Drug Product Module 3 and 2.3 Authoring: -New vaccine Biologics License Application – FDA: 32A1 Facilities and Equipment (General Overview Flow and Contamination Control), module 23S Quality Overall Summary. -CTD update Europe: Drug Substance Module 3 and 2.3 (32S22 description of Manufacturing Process, 32S23 Control of Materials, 32S25 Process Validation, 32S26 Manufacturing Process Development, 32S42 Analytical Procedures, 32S43 Validation of Analytical Procedures, 32S44 Batch Analysis). -CTD update Europe: 32A2 Adventitious Agents Safety Evaluation, 32R Table A and B, and corresponding module 2 sections. -CMC Variation Europe, type I.B, new validations of the Drug Substance intermediate holding times. -Pre-Qualified Vaccine Annual Reports - WHO (annual stability studies, information on production). -Q&A to Health Authorities: Validation of filled syringe sterilization. -Renewals: Stability studies, certificate of analysis (DS, DP, adjuvants). Team activity: -Training: Vaccine Manufacturing Awareness (15 people). -Redesign of the workrequest forms (between Sanofi Pasteur and Umanis). Show less
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Sanofi Pasteur
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Regulatory Affairs CMC internship
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Apr 2016 - Sep 2016
Authoring: -New vaccine Biologics License Application – FDA: 32S22 Description of Manufacturing Process and Process Control – Transportation; 32S26 Manufacturing Process Development (Extractables and Leachables, Transportation); 32S25 Validation of Purification Equipment Lifespan and Holding Time. -Briefing Package for a Type C CMC meeting with the FDA: Information to support the characterisation of endogenous particles study and analytical method summaries. Operational… Show more Authoring: -New vaccine Biologics License Application – FDA: 32S22 Description of Manufacturing Process and Process Control – Transportation; 32S26 Manufacturing Process Development (Extractables and Leachables, Transportation); 32S25 Validation of Purification Equipment Lifespan and Holding Time. -Briefing Package for a Type C CMC meeting with the FDA: Information to support the characterisation of endogenous particles study and analytical method summaries. Operational support: -Regulatory assessment of Europe versus US Module 3S requirements based on FDA approved dossier, internal templates. -Identification and tracking of international Post Approval Commitments taken in Health Authorities Q&A documents. -Implementation of a Q&A from Health Authorities database for a new vaccine (Q&A document IDs, key words, CTD sections involved in question and/or answer, …). Show less Authoring: -New vaccine Biologics License Application – FDA: 32S22 Description of Manufacturing Process and Process Control – Transportation; 32S26 Manufacturing Process Development (Extractables and Leachables, Transportation); 32S25 Validation of Purification Equipment Lifespan and Holding Time. -Briefing Package for a Type C CMC meeting with the FDA: Information to support the characterisation of endogenous particles study and analytical method summaries. Operational… Show more Authoring: -New vaccine Biologics License Application – FDA: 32S22 Description of Manufacturing Process and Process Control – Transportation; 32S26 Manufacturing Process Development (Extractables and Leachables, Transportation); 32S25 Validation of Purification Equipment Lifespan and Holding Time. -Briefing Package for a Type C CMC meeting with the FDA: Information to support the characterisation of endogenous particles study and analytical method summaries. Operational support: -Regulatory assessment of Europe versus US Module 3S requirements based on FDA approved dossier, internal templates. -Identification and tracking of international Post Approval Commitments taken in Health Authorities Q&A documents. -Implementation of a Q&A from Health Authorities database for a new vaccine (Q&A document IDs, key words, CTD sections involved in question and/or answer, …). Show less
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Research Project Manager
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Feb 2009 - Jul 2012
UMR 7179 MECADEV (MNHN/CNRS); URA 2210 (CEA/CNRS); Hoffman-LaRoche Preclinical study of cerabral aging biomarkers and non-clinical therapeutic study • Project management, long-range planning • Protocol development (Behavior, Histology, Functional Imaging) • Adaptation and Implementation of image processing (Histology, Functional Imaging) • Preclinical study day-to-day work • Results analysis and statistic analysis • Scientific monitoring • Management… Show more UMR 7179 MECADEV (MNHN/CNRS); URA 2210 (CEA/CNRS); Hoffman-LaRoche Preclinical study of cerabral aging biomarkers and non-clinical therapeutic study • Project management, long-range planning • Protocol development (Behavior, Histology, Functional Imaging) • Adaptation and Implementation of image processing (Histology, Functional Imaging) • Preclinical study day-to-day work • Results analysis and statistic analysis • Scientific monitoring • Management (trainee) • Writing (French, English) • Communications Show less UMR 7179 MECADEV (MNHN/CNRS); URA 2210 (CEA/CNRS); Hoffman-LaRoche Preclinical study of cerabral aging biomarkers and non-clinical therapeutic study • Project management, long-range planning • Protocol development (Behavior, Histology, Functional Imaging) • Adaptation and Implementation of image processing (Histology, Functional Imaging) • Preclinical study day-to-day work • Results analysis and statistic analysis • Scientific monitoring • Management… Show more UMR 7179 MECADEV (MNHN/CNRS); URA 2210 (CEA/CNRS); Hoffman-LaRoche Preclinical study of cerabral aging biomarkers and non-clinical therapeutic study • Project management, long-range planning • Protocol development (Behavior, Histology, Functional Imaging) • Adaptation and Implementation of image processing (Histology, Functional Imaging) • Preclinical study day-to-day work • Results analysis and statistic analysis • Scientific monitoring • Management (trainee) • Writing (French, English) • Communications Show less
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Research Assistant
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Jan 2008 - Jul 2008
Central Nervous System Dept., R&D Non clinical study, diabetic neuropathy, animal model • Behavior • Histology Central Nervous System Dept., R&D Non clinical study, diabetic neuropathy, animal model • Behavior • Histology
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Research Assistant
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Sep 2006 - Aug 2007
URA 2210 (CEA/CNRS) Preclinical biomarkers of cerebral aging, feasability study • Planing • Protocole development (Histology, Functional imaging) • Statistical analysis • Writing and communications URA 2210 (CEA/CNRS) Preclinical biomarkers of cerebral aging, feasability study • Planing • Protocole development (Histology, Functional imaging) • Statistical analysis • Writing and communications
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Research Assistant
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Feb 2006 - Feb 2006
Cerebral imaging study of schizophrenia endophenotypes • Control subjects enrolement • Patients training • Protocol development assistance Cerebral imaging study of schizophrenia endophenotypes • Control subjects enrolement • Patients training • Protocol development assistance
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Education
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2009 - 2012
Université Paris Descartes
Doctor of Philosophy (Ph.D.), Neuroscience -
2006 - 2007
Université Paul Sabatier (Toulouse III)
Master 2 Professionnel, Biosanté, Méthodes Biologiques et Evaluation des RIsques pour l'Homme (nouveau BioTox) -
2006 - 2007
Université Pierre et Marie Curie (Paris VI)
Master 2 Recherche, Biologie Intégrative et Physiologie, spécialité Neurosciences -
2002 - 2006
Université Claude Bernard Lyon 1
Master 1, Biologie Intégrative: Physiologie et Neurosciences -
2007 - 2007
Ecole nationale vétérinaire de Toulouse
Niveau 1, Utilisation et Protection de l'Animal de Laboratoire -
2015 - 2016
ESTBB - Ecole Supérieure de Biologie - Biochimie - Biotechnologies
Diplôme Universitaire, IPROB 8 Parcours de professionnalisation -
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