Joseph Bibeault, M.S. Email & Phone Number

Boston, Ma, Us

Watertown, Ma, Us

Leader of Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for Recipharm's biologics CDMO division, ReciBioPharm. I advise clients on CMC best practices in early and late phase development for mRNA, Live Biotherapeutic Products, and CGT products. Ensure source-documentation is submission-ready, and provide regulatory writing support for client investigational and commercial applications.

Boston, Ma, Us

Lecturer in Regulatory Affairs CMCRGA 6410 - Fundamentals of CMC Regulations and MethodsRGA 6275 - Product Development and Process Validation

Paris, France, Fr

U.S. Chemistry, Manufacturing, and Controls; Dupixent Global Reg CMC Manager; Global Reg CMC manager for Libtayo; Global Reg CMC manager for clinical Phase 1 clinical program; assess global regulatory impact for planned changes to CMC; Review, approve, and submit regulatory documents to FDA, Health Canada, European Medicines Agency (i.e Annual Report, BLA/MAA Supplements, etc.); Liaise with global drug manufacturing sites to ensure Regulatory compliance with US and RoW markets; Support pipeline development products and submissions; Support Regulatory Affairs initiatives (I.e. Veeva Vault RIM Registration Tracking SuperUser)

Paris, France, Fr

U.S. Chemistry, Manufacturing, and Controls (CMC) product manager for Kevzara (sarilumab); Global clinical CMC support for Libtayo; global commercial CMC product point of contact for Libtayo; assess United States regulatory impact for planned changes to CMC; Review, approve, and submit regulatory documents to FDA, Health Canada, European Medicines Agency (i.e Annual Report, BLA/MAA Supplements, etc.); Liaise with global drug manufacturing sites to ensure Regulatory compliance with US and RoW markets; Support Regulatory Affairs initiatives (I.e. Veeva Vault RIM Registration Tracking SuperUser)

Paris, France, Fr

I supported the Manufacturing Science and Technology’s (MSAT) up and coming development lab for Sanofi Process Science. We worked on therapeutic monoclonal antibodies products such as Dupilumab and Alirocumab, enzyme replacement therapies, and next generation products. Some of my daily tasks: I purchase equipment, maintain laboratory compliance through health and safety initiatives, autoclave lab equipment, and make media and buffer solutions for our process development experiments.

Paris, France, Fr

My role in this position is to learn and gain experience in the Global Regulatory CMC area. I spend 20% of my time in this role and provide support to a team of Regulatory professionals. A goal of this preceptorship will be to maintain and update dossiers, evaluate change controls, and submit to health authorities for some small global Sanofi products. This program ended in October 2018.

Paris, France, Fr

Large scale cell culture process operator. Experience in large scale perfusion cell culture operations, small scale sampling and inoculation, CIP and SIP processes, preventive maintenance, microfiltration/diafiltration skid operation, and extensive experience with the DeltaV process management platform.

Cupertino, California, Us

Master Of Science - M.S., Regulatory Science

Bachelor Of Science - B.S., Biology

Bachelor Of Arts - B.A., French And Francophone Studies

French Language Immersion, French Studies

Associate Of Arts - Aa, General Studies