Industrial pharmacist with a Master 2 in bio-manufacturing and microbiologic controls.
Mes compétences :
Microsoft office
BPF
Biotechnologies
Assurance Qualité
Downstream
Upstream
Vaccines
Entreprises
Sanofi Pasteur
- Critical Material Management Subject Matter Expert
Lyon2016 - maintenantSwiftwater, PA, USA
PROJECT: Ensure compliant and quality raw materials are used in bacterial vaccines.
- Project Management: co-leader, creation and update of monitoring tools, KPI reporting, project plan and budget definition
- Assess raw materials risks:
Suppliers change notifications review
Critical raw materials assessment and ranking
- Reduce raw materials risks:
Define user requirements
Identify new suppliers
Screen new raw materials at small-scale (Upstream and Downstream)
Lead Change Controls (Trackwise, Phenix)
Generate and approve documents (study protocols and reports, risk assessment report, Quality Technical Agreement, procedures and guidelines)
Coordinate executive work
Project: Ensure compliance of a bulk manufacturing building and increase reliability of two bacterial bulks purification processes.
- Project Management: human resources, budget, delivery times, stakeholders coordination, KPI reporting
- Direct and transversal team management
- Critical Process Parameters Assessment: methodology, workshops, reports
- Replacement of old equipment (UF skid, dead-end filtration system, tubular centrifuge, CIP station):
Definition of user requirements for equipment and automated system related
Process and cleaning validations (change control, strategy, protocols, reports)
- Other activities: change of air grade (D to C), knowledge improvement on toxoids.
Sanofi Pasteur
- Apprentice - Manufacturing unit of bacterial antigens
Lyon2012 - 2013Marcy l'Etoile, 69, France
- Simplification of particles deviations management (root cause assessment, quality impact evaluation taking into account chemical compatibilities),
- Mapping of activities (load/capacity analysis),
- Involvement in the beginning of the manufacturing process (redaction of a procedure on the organization of fixed and mobile equipments cleanings, review of batch records),
- Preparation of the OHSAS18001/ISO14001 certification (redaction of deliverables).
Saint-Germain-en-Laye2012 - 2012Marcy l'Etoile, 69, France
Corporate Standards implementation affecting organization and responsibility of the laboratory in order to standardize practices in relation to continuous quality improvement according to ICHQ10.
Protocols authoring and risk analysis to define reagents criticity and justify equipment qualifications periodicity.
Interaction analysis between cola beverages and methotrexate.
Efficacity assessment of Aprepitant in children for the prevention of chemotherapy induced nausea and vomiting.
Pharmacoeconomic assessment of two drugs used in the treatment of children ALL in order to introduce a more effective medicine.
Cohort study: Atazanavir exposure impact on the renal function.
Document monitoring, research of the potentially responsible Single Nucleotide Polymorphisms in order to predict Atazanavir side effects.
IDECAF - Ho Chi Minh City (Vietnam)
- French teacher
2011 - 2011Ho Chi Minh City, Vietnam
Theatre courses and French lectures. Organization of the end-of-year performance.
Ecully2013 - 2013Additional training during my Master 2 degree:
- Team management
- Communication
- Accountability
- Marketing
- Pharmaceutical industry challenges
Lyon2006 - 2013Thèse (en cours) : Maîtrise de la contamination croisée
Industrial field.
Specialization 1: « Biodrugs and bioprocessing »
Specialization 2: « Preformulation and Biodisponibility of health products, scientific English »
