Eric Leblanc, RAC-US
Associate Director, CMC Services @ Premier Research
About
CMC – Regulatory Affairs professional with twenty-five years of professional experience. Deeply experienced in CMC pharmaceutical drug development, regulatory affairs, project management and Quality Assurance compliance. Regulatory Affairs Certified (RAC). Certified Associate in Project Management (CAPM).
Canada
Greater Montreal Metropolitan Area
Biotechnology
Technologies de stockage des données, Communication avec les clients, Anglais, CMC Regulatory Affairs, IND, Biopharmaceuticals, Regulatory Affairs, GMP, Regulatory Submissions, Sop, Quality Assurance, SOP, Validation, Technology Transfer, GLP, Drug Development, CAPA, Protein Chemistry, Biotechnology, Pharmaceutical Industry
Experience
Associate Director, CMC Services
Premier Research
Montréal, Québec, Canada
Senior Manager, CMC Development Strategy
Premier Research
Montreal, Quebec, Canada
Consultant: CMC - Regulatory Affairs, Quality Assurance, Project Management
Eric Leblanc Consultant Inc.
- Project management for biopharmaceutical products development programs. - Biopharmaceutical CMC and regulatory support for the development of recombinant proteins, monoclonal antibodies, antibody – drug conjugates and vaccines. - Coordinate stability studies for Drug Substance and Drug Product. - Generation of Standard Operating Procedures, Deviation impact assessment and implementation of CAPA. - Drug inventory keeping and logistics. - Batch record and data review for batch disposition.
Senior Manager, Regulatory Affairs, CMC
Camargo, A Division of Premier Research
Senior Scientist, CMC Services
Camargo Pharmaceutical Services
Montreal, Quebec, Canada
Regulatory Affairs Specialist
Enobia Pharma
- CMC - Regulatory Affairs support for the development of a recombinant enzyme. - Coordinate, prepare, and review document packages for submission to worldwide regulatory agencies. - Maintain regulatory files and manage timing of submissions.
Quality Specialist
Enobia Pharma
- Write and review the CMC sections for regulatory submissions. - Batch records review and batch disposition. - External vendor GLP and GMP audits. - External vendor and CMO management. - Drug Product forecast for clinical studies. - Stability program manager. - Preparation of SOPs.
Research Associate and Quality Assurance Associate
Enobia Pharma
- Recombinant enzyme expression, purification and formulation. - Protein characterization. - Technologie Transfert to CMO for large scale protein purification. - Manager of the purified protein stocks. - General laboratory and equipment maintenance. - Batch records review and batch disposition. - External vendor GLP and GMP audits. - External vendor and CMO management. - Write and review the CMC sections for regulatory submissions. - Drug Product forecast for clinical studies. - Stability program manager.
Research Associate
Enobia Pharma
Montreal, Canada Area
- Recombinant enzyme expression, purification and formulation. - Protein characterization. - Manager of the purified protein stocks. - General laboratory and equipment maintenance.
Education
Université de Montréal
biochimie
Eric Leblanc, RAC-US's Contact Information
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