Héloïse Fonteneau Email & Phone Number

Nantes, Fr

Nantes, Pays De La Loire, France

Strategy and management of QMS for Nantes Laboratory of Gene Therapy for the activities of research, development, manufacturing and analytical trial laboratory for clinical studies regarding advanced therapy medicinal products.Tasks:- Participation to Executive commitee of the laboratory, in charge of global management reviews- Management of the quality team (up to 4 collaborators)- Strategic and operational management of SMQ- Certification ISO 9001:2015 for the whole laboratory- Compliance of laboratory to the relevant norms and guidelines (GMP, GcLP, ICH etc.)- Risk management, validation plan of bioanalytical methods- Management of deviations, change controls, continuous improvement- Quality agreements, audits, CAPA- Quality Assurance Teaching (master level)- In charge of CSR policy- Consulting for external customers (QMS, VMP, audit, advisory, certification etc.)Skills: Management; QMS; Audit; CAPA; Planning; Risk management; Validation plan; ISO 9001; GcLP; First Aid representative; CSR

Nantes

In charge of quality assurance and regulatory. Asset in a start up developing innovative medical solution to drug resistant bacterial infections: bacteriophages (regulatory equivalent to human vaccines).Set up de novo the quality and regulatory system:- Set up quality management system within the company and regulatory watch (GMP, ISO 9001, European Pharmacopeia)- Risk management- In charge of audit and CAPA- Monitoring of the project development conformity- Part of manufacturing and quality control specifications set-up for human sterile drugs- Contracts and Quality Agreement for sub-contractorsSkills:Audits ; CAPA ; Planning ; Risk management ; Transversal management; GMP; ISO 9001; European Pharmacopeia; Cross-functional and Inter-cultural communication; First Aid representative

Marseille Area, France

Senior analyst responsible for coordinating R&D projects. Project management for development of complex FDA-regulated immunoassays.- Responsible for monitoring and driving project plans and timetables through design input definition, characterization plan, verification plan and visual management of the projects.- Development of the assay in compliance with the FDA (510K, PMA), CFDA, AFSSAPS and customers' requirements; Development through the following phases: feasibility, planning, design and qualification of the assay.- Risk analysis and management.- Support between R&D, Quality assurance, Manufacturing, Regulatory and Marketing.- Collaborate interdepartmentally & intercountry (mainly France, Ireland, USA, China).- Enhancing relations with customers by taking part to congresses (IFCC, AACC…) and setting up trainings within customer’s laboratory.- Work under GMP, ISO 9001 and ISO 13485.Skills:Design input; Characterization plan; Verification plan; Visual Management ; Planning ; Risk management; Transversal management; GMP; ISO 9001; ISO 13485; First Aid representative, Congresses (IFCC, AACC)

Marseille Area, France

Development of Immunodiagnostic assays for Access and DxI high-throughput hardwares.- Development through the following phases: feasability, planning, design and qualification.- Development of the assay in compliance with the FDA (510K), AFSSAPS (CE marketing) and customers' requirements;- Participating in cross-functional meetings and support of R&D, Quality assurance, Manufacturing, Regulatory and Marketing (French, English).- Writting of protocols, technical reports in French and English.Skills:Immunological assays; Statistical analysis (JMP); Writting of protocols and technical reports; Standard work; First Aid representative training

Marseille Area, France

Investigation of new technologies in order to better address Beckman customer needs.- Project analysis of scientific, technologic, economic feasibility;- Formulation and development of Immuno Assays or Flow cytometry assays, including: o Quantitative analysis of the technology performances; o Technology control, Key Performance Factors control, reflection about the system integration, estimation of the costs;- Drafting of high quality documentation for the formulation tests, protocols, work instructions and reports in either French or English.Skills:Design of Experiments (software JMP); Literature interpretation; Management of experiment analysis and faisability

Orange County, California Area

Scientific Management Development Program. Training of a select group of scientist in all aspects of product development, including one-on-one interaction with all senior management. - 4 months in Molecular Diagnostic R&D at Danvers, MAResearch & Development of a new RNA extraction/purification process for the use of plasma and serum in the quantitative determination of the virus of Hepatitis C on the DxN- 4 months in Flow Cytometry R&D at Marseille, FranceResearch & Development of a new compensation issue remediation system. Innovative, fast, simple system of compensation for cytometry using 2 to 10 dyes.- 4 months with the Scientific Affair department at Brea, CaliforniaInterpretation of litterature, and research of results produced by independant labs. Writting of reviews concerning the clinical impact of the blood cell subpopulations CD16+ monocytes and CD16+ TNK lymphocytes.Participation and presentation at Application Specialist training and Key Opinion Leader Meeting.Skills:Design of Experiment (software JMP) ; Troubleshooting ; Litterature interpretation ; Application Specialist training ; KOL meeting

Saint-Herblain

Transition to a security level B for an area of biopharmaceutical material production. Writing of internal quality document and corrective and preventive actions design (CAPA).

Saint-Harblain (France)

Screening and optimization by DoE (JMP Software) of Chemically Defined media. Avian stem cell culture (EB66 cell line), production of therapeutic viruses (MVA poxvirus).

Saint-Aubin-Lès-Elbeuf (France)

Scaling-up of a Working Cell Bank production from 250mL Erlenmeyer to 2L bioreactor.Writing of a cleaning protocol.

Engineer'S Degree, Biochemistry, Toeic : 950/990

Biochemistry ; Biology ; Microbiology ; Physiology ; Genetics ; Enzymatic engineering ; Heat and mass transfer ; Physics ; Optics.

Master'S Degree, Innovation Management

Innovation management ; International management strategy ; Financial engineering ; Innovative products and services management ; Legal.

Semester Of Study, Biochemistry

Molecular biology and genetics ; Downstream processing in biotechnology ; Physical methods of structural determination of organic.