Patrick Leclerc

Management of the supply chain of commercial drug products for the US market. -Development of supply strategies; -Selection and management of vendors (raw material suppliers; manufacturing, packaging and storage facilities, distributor); -Forecasting; S&OP leader; -Planning of manufacturing and packaging campaigns; -Raw material and finished product transportation; inventory management; -Budget planning and monitoring; management of requests for proposal, POs, and invoice approval

Support life science companies and associations achieve their goals. Advise the government on investment and innovation projects. -Analysis of investment and innovation business projects -Evaluation of current trends and challenges in the life sciences industry -Action plan and strategy proposals to promote the growth of Quebec’s life science sector -Project assessment in the context of calls for proposals

Management of a team (2 employees) responsible for the supply of investigational products (IP) for clinical and early access programs (EAP). -Development of supply strategies for blinded and open-label clinical studies and EAP -Selection and management of vendors (manufacturer, distributor, CRO) -IP demand forecasting -Manufacturing and labeling campaigns planning -Supervision of inventories and movements across depots and clinical sites; EU importation and IP certification -Budget planning and monitoring; management of requests for proposal, POs, and invoice approvals

Working with clients and partners to obtain and maintain the marketing authorization of Drug Products in Taiwan, Philippines and South Africa. -Evaluation of new business opportunities -Preparation of registration dossiers (CMC) -Management of deficiency letters -Post market dossier maintenance including change control impact evaluation

Selected by the Quality heads to be part of a task team participating in a quality improvement program. -To review and approve investigation reports prepared by the QC laboratory. -To coach the analysts and supervisors in writing clear and thorough investigation reports. -To write QA investigation reports determining the cause of events, the related risks and impacts, the disposition of lots as well as CAPAs.

To supervise a team of 7 people responsible for the creation and the update of the specifications for API, Excipients, Drug Products and Packaging components.

Gére les activités de l'équipe de Programme de stabilité. Gére les activités de l'équipe de Spécifications. - Investiguer les DMF (Drug master file) et les pharmacopées. - Préparer les spécifications d’analyses et destinées à divers marchés pour les excipients, composantes d’emballage, ingrédients actifs et produits finis. Agit en tant que spécialiste stabilité et spécification pour: - le développement et l’implantation d’un système LIMS; - l’évaluation des risques associés à l’achat de dossier d’autres compagnies (in-licensing).

Gère 2 équipes (18 personnes): Programme de stabilité: protocole d'études, gestion des chambres et de l'inventaire, analyse de résultats et écriture de rapports. Laboratoire de stabilité: gestion du laboratoire, investigation.