As an Associate Partner in L2 Consulting, Sylvain Mandeville is a dynamic, results oriented professional with over 25 years experience in the pharmaceutical industry including over 18 years of experience in managing regulated laboratories and/or sites.
An agent of change as well as being a strategic thinker involved inthe re-organisation or set-up of laboratories in various countries (Canada, USA, UK, France, Hungary, Singapore and Australia). Familiar with the various processes required from API (manufacturing solid, liquid and biologics) until proof of concept including tech transfer.
As a pharmaceutical consultant, involved in technical/operational services to CRO, biotech and pharmaceutical companies regarding their quality systems (GLP and/or GMP) to meet FDA (in particular 21 CFR part 11, 210, 211 and 820), EMEA, ICH and ISO standards as well as preparing sites (mock audit and QSIT) prior to regulatory audits.
Sylvain Mandeville Phd