Denis Haché
Associate Director, Bioanalysis @ Charles River Laboratories
About
With over 30 years of experience in Analytical and Bioanalytical Services of preclinical and clinical CROs and in Pharmaceutical Quality Control, I acquired excellent knowledge of budgetary control, project management and staff management. I have strong client service skills and excellent skills in resolution of problems and process optimization, Membre de l'Ordre des chimistes du Québec Spécialisations : Design new laboratory, continous process improvement, effective cost control, quality control, compendial method (USP, EP, JP), ability to manage of variety of preclinical and clinical support services.
Canada
Greater Montreal Metropolitan Area
Pharmaceuticals
Contrôle d’instruments, Instrumentation, Gestion budgétaire, Planification opérationnelle, Travail d’équipe, HPLC, GLPs, Pharmaceutical Industry, LC-MS, Laboratory, CRO, Team Management, 21 CFR Part 11, Laboratoire, GMP, Quality Auditing, SOP, Analytique, Bioanalysis, Gestion de la qualité
Experience

Supervisor, Instrumentation
Senneville, Québec, Canada
- Supervise, train and coach a team in continuos process improvement. - Communicate the quality goals, performance goals and health and safety goals to the team. - Maintain a optimal productivity and efficiency by using key peformance indicators. - Ensure the integrity of instrument preventive maintenace and repairs. - Responsible of the recrutment and the daily resource planning. - Manage the operational budget.

Supervisor, Clinical Laboratories
Senneville, Québec, Canada
- Supervise, train and coach a team in continuos process improvement. - Communicate the quality goals, performance goals and health and safety goals to the team. - Maintain a optimal productivity and efficiency by using key peformance indicators. - Ensure the integrity of studies and meet the requirements of regulatory agencies. - Responsible of the recrutment and the daily resource planning. - Manage the operational budget.

Manager Quality Control
Région de Montréal, Canada
Overview the Quality System in the Chemistry, Incoming QC and Microbiology laboratories. - Compare the Standard Testing Methods against relevant pharmacopeias and approved submitted methods. - Establish and implement basic procedures, training requirements, programs, and techniques consistent with company policies and standards to achieve quality control objectives. - Participate in the resolution of process deviations and product failures by providing investigation reports sufficient to aid in the diagnosis and goods. - Provide leadership and technical support of quality objectives to staff and outside departments.

Quality Control Supervisor
Région de Montréal, Canada
Overview the Quality System in the laboratories. - Compare the Standard Testing Methods against releveant pharmacopeias and approved submitted methods. - Establish and implement basic procedures, training requirements, programs, and techniques consistent with company policies and standards to achieve quality control objectives. - Participate in the resolution of process deviations and product failures by providing investigation reports sufficient to aid in the diagnosis and goods. - Provide leadership and technical support of quality objectives to staff and outside departments.

Quality Control Supervisor
Région de Montréal, Canada
Overview the Quality System in the laboratories. - Compare the Standard Testing Methods against releveant pharmacopeias and approved submitted methods. - Establish and implement basic procedures, training requirements, programs, and techniques consistent with company policies and standards to achieve quality control objectives. - Participate in the resolution of process deviations and product failures by providing investigation reports sufficient to aid in the diagnosis and goods. - Provide leadership and technical support of quality objectives to staff and outside departments.

Quality Control Supervisor
Montreal
- Overview the Quality System in the laboratories. - Compare the Standard Testing Methods against releveant pharmacopeias and approved submitted methods. - Establish and implement basic procedures, training requirements, programs, and techniques consistent with company policies and standards to achieve quality control objectives. - Participate in the resolution of process deviations and product failures by providing investigation reports sufficient to aid in the diagnosis and goods. - Provide leadership and technical support of quality objectives to staff and outside departments.

Program Support Clerck
Région de Montréal, Canada
- Participate in the production quality documents from the division. - Make travel reservation and complete expenses account for the manager. - Do filing and updating records manager in accordance with the procedures for information management at the beginning of each month.

Crew Leader - Census 2011
- Plan and distribute assignment tasks to a team of 15 enumerators. - Perform efficient client service to the respondents. - Answer to the public service request either by phone or by a visit - Control the costs related to the different tasks performed by the enumerators on the field

Director of Laboratories
LAB Research
- Plan and control the budget of the different laboratories: Analytical, Bioanalytical, Clinical Pathology, Immunology and Pharmacy. - Coordinate with the different department heads the preparation and analysis of samples according to SOP’s, protocols and Good Laboratory Practices (GLP’s) ; - Approve Analytical, Bioanalytical and Immunology reports, method SOP, SOP deviations and investigation reports; - Promote the different laboratory services; - Participate in client and regulatory agency audits

Director, Analytical Services
LAB Research
- Evaluate equipment and instruments necessary for the new Analytical and Bioanalytical services; - Put in place procedures and SOPs for the new services; - Hire qualified personnel for the Analytical and Bioanalytical laboratories; - Control validation activities for instrument and software (electronic compliance) ; - Prepare and approve quotes sent to sponsors for method validation and sample analysis studies; - Plan sample analysis (dosing formulation and biologic samples) according to protocols, SOP’s and GLP’s; - Approve Analytical and Bioanalytical reports, method SOP, SOP deviations and investigation reports; - Participate in client and regulatory agency audits.

Manager, Analytical
- Evaluate daily activities of the analytical team : validation and sample analysis of dosing formulation and biological samples; - Evaluate the quality and competency of the Analytcal staff members; - Evaluate the global quality and supporting documentation of the analyses.

Director, Bioanalytical Sector, Bioanalytical Division
Anapharm
- Supervise a team of professionals and technicians ; - Supervise the work of quality inspectors of the division ; - Control the activities of instrument and software validation for the division (electronic compliance) ; - Plan and control the budget for the bioanalytical sector ; - Participate in revision of divisional and corporate standard operating procedures (SOP) to make sure that they are compliant to the different regulatory agencies ; - Approve bioanalytical reports, protocol and SOP deviations, bioanalytical method SOP and investigation reports ; - Participate in client and regulatory agency audits ; - Assist to operation and integration committee.

Assitant-Director, Bioanalytical Division
Anapharm
- Supervise a team of project coordinators and technicians ; - Plan the work of project coordinators and laboratory technicians and as well the analytical instrument utilization (LC/MS/MS, LC/MS, GC/MS, GC and HPLC) ; - Participate to the preparation and control of the bioanalytical budget ; - Collaborate to the revision of divisional and corporate standard operating procedures (SOP) to make sure that they are compliant to the different regulatory agencies ; - Approve protocol and SOP deviations ; - Communicate with internal and external clients.

Project Manager, Bioanalytical Division
Anapharm
- Supervise a team of assistant supervisors and technicians ; - Schedule sample analysis according to SOP, protocols and Good Laboratory Practices (GLP) ; - Optimize the utilization of analytical instruments (LC/MS/MS, GC/MS, GC and HPLC) ; - Interact with other services and divisions of the company and with clients ; - Hire and evaluate personnel

Project Manager, LC/MS Department
- Supervise a team of scientist reviewers and laboratory technicians ; - Schedule sample analysis and bioanalytical method validation of LC/MS and LC/MS/MS projects according to SOP, protocols and Good Laboratory Practices (GLP). - Manage all bioanalytical projects using automated on-line extraction in order to reduce the client timelines.
Denis Haché's Contact Information
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