Experience

Bio Elpida

• France
• Biotechnology
• 1 - 100 Employee

• Chef de projet développement pharmaceutique

  • May 2021 - Present

  • Project manager for development and submission of New therapy cell based sterile drug products for Cancer treatment in all clinical phases. ( 1 – 3 ) • Accountable for all the phases of the project from development to regulatory dossier submission and approval • Writing of contracts and URS documents for clients following requests required for the Project. • Lead Projects Technology Transfer activities from development to GMP site. • Update on Project Schedule, budget, Quality, conflicts and progress to internal and external stakeholders (International ) • Project Planning design, update and communication • Define, Lead, organize and resume Project Team meetings • Link and support technical meetings between client and internal scientific stakeholders. • Risk and conflict Project TEAM management • Project Budget Management including project global budget definition, updates to financial department, incomes and expenses management. • Work in close collaboration with QA and RA department to ensure Project the client requirements and Pharmaceutical Quality Standards. • Lead QbD and process transfer meetings for set up in development product process • Project lead of construction of a new GMP room for product GMP manufacturing required for projects • Cross Functional Team management Show less



Mylan France

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmaceutical Development and LCM Project Manager

  • Feb 2014 - Sep 2017

  • Technology Transfer and development Project Management of injectable pharmaceutical products for European and North American Market • Internal and external (CRO) cross functional leading (international) • Follow up of Milestones and projects task to comply with the planned timelines. • Injectable Drug Products Life Cycle Project Management (continuous improvement). • Change Control management following requirements of Tech Transfer and Life Cycle Management Projects. • Technical support for projects with a high degree of Quality/Regulatory Risk. • Set up of a Technology Transfer SOP for Pharmaceutical products following QbD requirements. • Organization, planning and follow up of Milestones and main tasks of projects for Pharmaceutical injectable products registration in the North American market. • Reviewal and approval of reports and protocols for bioequivalence studies. • Coordination of manufacturing and control testing of pilot submission batches. • Testing results analysis and interpretation. • Reviewal and approval of quality documentation executed. • Coordination of manufacturing and control testing of pilot submission batches by CRO. Show less



Becton Dickinson

• Région de Lyon, France

• Technology Transfert Engineer

  • Nov 2011 - Feb 2014

  • Management and follow up of pharmaceutical-medical devices transfer projects to comply with the timing and quality required. • Design, coordination and follow up of batches required for design scale up and registration (technical, study and stability batches). • Scale-up and scale-down studies. • Quality documentation accountable following cGMP requirements: Protocols and Reports and documentation change control management. • Technical support to regulatory team during registration of new drug products. • International Work in collaboration with developing site (France) and manufacturing site (USA) Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Internship Autonomus maintenance deployment

  • Feb 2011 - Sep 2011

  Deployment of Autonomus maintenance for sterilizing equipment anf vaccins production. Deployment of Autonomus maintenance for sterilizing equipment anf vaccins production.



Martin & Harris Pvt. Ltd. - Past Distributor of Merck, Schering Plough and Organon

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Researcher - Galenist

  • 2008 - 2010

  • Formulation and development of new pharmaceutical products (solids, liquids and semi-solids). • Design of formulation and process experiments. • Accountable for pilot and stability batches: • Analysis and results interpretation • Creation of cGMP quality documentation required for submission (Protocols and Reports). • Assisting for Equipment Qualification activities of new incoming equipment for cGMP compliance of new pilot plant. • Formulation and development of new pharmaceutical products (solids, liquids and semi-solids). • Design of formulation and process experiments. • Accountable for pilot and stability batches: • Analysis and results interpretation • Creation of cGMP quality documentation required for submission (Protocols and Reports). • Assisting for Equipment Qualification activities of new incoming equipment for cGMP compliance of new pilot plant.