Kante SEMBELOU

En résumé

Entreprises

• Stallergenes - Immuno-analysis Development Team Manager & Project Manager

  ANTONY 2011 - maintenant - Team management:
  • Managed a team of laboratory staff (7 technicians and 1 assistant).
  • Day-to-day management: scheduling, planning resources, organizing workload and setting objectives for the team. Ensure the team worked efficiently and met deadlines, while continuously developed new skills and improved its performance.
  • Measured the team performance against the KPIs.
  • Managed supply of consumables and reagents within budget.
  • Implemented and followed 5S workspace organization method in the laboratory.
  • Participated in the implementation of lean management in the laboratory.
  
  - Technical activities:
  • Developed, optimized, validated and transferred immunological analytical methods: wrote, reviewed and approved protocols, results interpretation and reports.
  • Responsible of full cycle analyses, ensuring GMP compliance, from sample preparation to results interpretation (using statistical approaches) for:
  o Source materials, in process samples, drug substance and final product under development,
  o Process development and process validation samples.
  • Analyzed samples for investigations and results interpretations (with the client when needed).
  
  - Project management:
  • Planned and drove projects to meet deadlines in a challenging environment.
  • Organized, delegated, coordinated and monitored functional team activities, timelines and deliverables for each project.
  • Provided guidance, support and technical expertise to Quality Control to ensure that manufactured products meet applicable regulatory standards.
  • Participated in team project meetings.
  • Designed and specified stability protocols and set up specifications (at release and shelf life).
  
  - Regulatory activities:
  • Managed the documents for regulatory requirements.
  • Participated to eCTD submission: reviewed and approved eCTD components for module 3.
  • Answered health authorities’ questions and requests during files evaluation (European countries, Russia, Canada, Japan, USA…).
  
  
  - Quality assurance activities:
  • Management of quality events: out of specifications results, deviations, change control…
  • Updated operational procedures as and when required.
  • Active participation to audits for preclinical studies.
  
  ACHIEVEMENTS: FDA approved Oralair® in 2014, the first sublingual immunotherapy tablet for the treatment of grass pollen allergy, 6 years after its approval in Europe. This success represents a major milestone for Stallergenes and its expansion in the world. Marketing authorization was also obtained in Canada, Australia and Russia.

• Stallergenes - Quality Control Project Manager

  ANTONY 2008 - 2011 - Communication:
  • Interface between quality control department and customers (both internally or externally). Interacted closely with assigned customers to ensure project scope and milestones are well defined.
  • Built relationships with customers through frequent communication throughout the project and by ensuring their needs are met.
  • Appropriately kicked off, executed, and closed out projects.
  • Ensured team members understand project objectives, specifications, deliverables, timelines and tasks.
  • Provided project status information both internally and externally through the use of project team meetings, minutes, e-mail, teleconferences, and direct communication.
  • Worked both independently and in a team-oriented, collaborative environment.
  
  - Scheduling:
  • Developed and tracked projects development plans using PSNext.
  • Identified and tracked critical path/activities, risks and alternatives in every challenging situation.
  
  - Product analytical development:
  • Defined analytical strategies for development lots, method validation, stability studies and manufacturing process validation.
  • Establishment of products’ specification (source material to final product).
  
  - Regulatory activities:
  • Wrote, reviewed and approved eCTD sections (Module 3) for European and American markets, answered to authorities questions regarding submitted files.
  • Participated to teleconferences with German authorities during the Mutual Recognition Procedure (Europe).
  • Ensure compliance of regulatory files with French, European, Japanese and American Pharmacopoeias.
  
  ACHIEVEMENTS: Obtained the Marketing Authorization in Germany (reference country), then in 22 European countries following the successful filing for Mutual Recognition Procedure.

• Sanofi pasteur - Analytical Validation Training

  Lyon 2007 - 2007 • Identified product-analytical method pairs to be validated.
  • Evaluated compendial methods.
  • Organized team meetings to determine analytical methods validation strategies: wrote minutes and summarized action plan.
  • Established analytical validation matrix by defining products and methods to be evaluated.
  • Wrote validation protocols in collaboration with technicians of each analytical platform (Immuno-analysis, chemical and viral platforms).
  • Scheduled assays to be performed for each validation study and results interpretation using statistical analysis.
  
  ACHIEVEMENTS: Identified and scheduled analytical methods validations to be performed before inspections.
  

• Laboratoire Environnement et Chimie Analytique (CNRS) - Training in Environment and Analytical Chemistry Laboratory

  2006 - 2006 Staining of proteins involved in milk allergy
  Analysis of proteins by capillar electrophoresis and using miniaturized system.

Formations

• Université Paris 11 Paris Sud

  Chatenay Malabry 2005 - 2007 Master Degree in Quality Control of Health Products Emerging from Biotechnology

• Université Paris 11 Paris Sud

  Orsay 2001 - 2005 Licence de biochimie - DEUG Sciences de la vie - PCEM1

Réseau

• Alain NIFLE

• Amel BACQ

• Céline BAUDRY-TRONCHET

• Dohoué AVODE

• Eric POUSSET

• Itati DE SOUZA

• Line TAING

• Olivia ROURE

• Philippe HOERNEL

• Thuy BOUGEOIS