Laval, Quebec, Canada
Reporting to company President and CEO, leaded procurement, production planning and supply chain activities with a team of 20 employees.
Provided consulting services for regulatory compliance and for the development of CMC sections for new drugs applications.
Managed business relationships including launch projects for in-licensing deals. Maintained business plans and adhered to budgets. Acted as a primary point of contact between internal/external stakeholders for licensed services including distribution, marketing, sales, PSP, medical information.
Acted as the primary point of contact in the business relationship with CDMOs. Managed a sub-contracting budget representing revenues of 250M$. Managed all commercial aspects with CDMOs including various categories such as CapEx, formulation development, IP rights acquisition, manufacturing, packaging, laboratory services.
Acted as the QA site lead and led a team of 13 employees to assure plant compliance with cGMPs by maintaining all quality systems in place. Succeeded in all routine cGMP and Prior Approval Inspections as the inspector primary point of contact: FDA (no 483s), Health Canada, ANVISA.
Initiated and implemented a reformulation project leading to an annual saving of 5M$. Implemented a CMC expertise center to support multiple new drug applications and technical transfers. Led a team of 5 employees for the preparation regulatory strategies and submissions.
- Organic Letters, 2008, 10, 2841. (first author) - Advances in Experimental Medicine and Biology, 2009, 611, 183. (first author) - Journal of Organic Chemistry, 2011, 76, 4533-4545. (third author)