Alexandre has extensive experience in pharmaceutical production including injectable products. His work experiences in global companies and developing biotechs have enabled him to acquire a variety of skills:Pharmaceutical & Industry standards: GMP/GLP, FDA, ISO, EMA, Health Canada, ICH, PDA, USP-NF, HACCP, etc.Over 12 years of experience under standardized practicesAseptic Production & Sterility Assurance: Sterility Assurance Level guidance authorIn charge of designing and executing Aseptic Process SimulationsTrending of contaminants in cleanroomsReview of gowning, decontamination, cleaning and sterilization practicesCleanroom design and qualificationProduction Unit Management: Commercial experience in a plant producing up to 2M filled vials/weekManagement of multiple operating unitsCAPEX and OPEX planning and management Experienced in a syndicated workplaceProject Management: Production lead for clinical studies: Core Team member / subteam leaderImplementation of a new Production Scale-up for the Pilot UnitDesign and Qualification of a new vial filling lineQuality System: Experienced Lead InvestigatorCAPA determination and managementChange Control management and approval for Production or QA UnitRisk Assessments: Experienced in various risk assessment method (FTA, FMEA, HAZOP, etc.)Performed risk assessment for Production, QA, Maintenance Qualification and Validation: Qualification and validation of equipment as author, executor or approverValidation strategy on various topics: Cleaning, sterilization, irradiation, filtration, aseptic simulation, Purified water, Clean air, etc.Audits: Supplier Audit as Company representative and Subject Matter ExpertSubject Matter Expert during FDA, Health Canada or other auditsRegulatory Submissions:Participation to multiple Clinical phases submissions as Production Expert

- Management of a team of 6 professionals/engineers supporting the activities of Medicago Pilot Unit Operations- Industrialization of Small-Scale Processes- Receiving unit lead during scaling up and technology transfer from Small-Scale to the Pilot Unit

- Management of a team of 3 supervisors, 2 engineers and 23 technicians- Responsible for 10 operating units for Protein Purification from plants to Drug Substance- Equipment design and upgrade for new production scale- Qualification/Validation strategy- Operational and Capital Expenditure budgets

- Responsible for formulation/filtration/aseptic filling/vial inspection and packaging activities at Medicago Pilot Unit- Gap & Risk Analysis- Major/Critical Investigation Lead- Project Management – Process Improvement and integration of new technologies

In addition to the Senior Industrial Process Specialist Tasks:- Management of a team of 12 technicians and professionals- Responsible for buffer production, washing and sterilization of material- Involvement in the implementation of D365 inventory management system

- Review of current practices and process improvement- Major/Critical Investigation Lead- Quality System Lead for Industrial Process group

- Management of a team of 20 technicians- Responsible for Formulation/Filtration and Filling activities of injectable products- Planning and Coordination of activities with support departments

- Modification of 6 existing filling lines for Aseptic Compliance and Reliability Optimization- Risk Assessment and Implementation of corrective actions on existing filling lines- Development of Setup and Operation Work Instructions and Training of Technicians

- Lead Investigator to ensure the sterility of injectable products- Execution of aseptic simulation program- Change control Review and Approval- Quality Assurance representative on various projects- Subject Matter Expert during regulatory agencies inspections: Health Canada and FDA or Novartis company audits

- Responsible for the food safety of manufactured products- Compliance with HACCP standards and implementation of BRC standards- Quality Control Laboratory analysis

Pharmacology researcher on apoptosis

Biochemistry Laboratory II – BCM317Biology departmentSherbrooke University- Supervision and support of students during practical experiments;- Correction of student reports and laboratory notebooks

Master Degree in the Laboratory of Dr. Jean-Bernard DenaultDepartment of Pharmacology Faculty of Medicine and Health Sciences

Laboratory of Dr. Pierre H. Vachon, Sherbrooke Project: Mechanism of regulation of anoikosis - Transfection of cells in culture; - Observation of cell death induction by ISEL - RNA extraction for RT-PCR

Centre de médecine génique de l’Université de Montréal, ChicoutimiUnder the direction of Dr. Catherine Laprise and Dr. Francois W. Paradis. - Genotyping of individuals by polarization fluorimetry, Taqman or RFLP of a family cohort related to asthma; - Gene sequencing and detection of polymorphism sites; - Analysis of the expression level of a gene using real-time PCR; - Use of a Luminex-type device for polymorphism genotyping and pathogen detection.

Dojo of Shihan Donald Gaudreault, Chicoutimi - Teaching karate techniques to students (4 to 65 years old), groups of up to 40 people; - Teaching advanced techniques to black belt students; - Responsible at different levels for the activities of the organization.

Microbiology department, Maxxam Analytics inc, Montreal - Performing routine microbiological analyzes requested by customers on their food; - Detection of pathogenic bacteria and coliforms and comparison with standards; - Compilation of results for transmission to clients.