Denis Haché

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.

Country

Canada

City

Greater Montreal Metropolitan Area

Industry

Pharmaceuticals

Skill

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

Charles River Laboratories

Associate Director, Bioanalysis

Charles River Laboratories

LinkedIn
2024-9 - Present · 2 yrs 1 mo

Senneville, Québec, Canada

Oversee Staff Scientists in the conduct of their studies.

Charles River Laboratories

Supervisor, Instrumentation

Charles River Laboratories

LinkedIn
2023-6 - 2024-9 · 1 yr 4 mos

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.

Charles River Laboratories

Supervisor, Clinical Laboratories

Charles River Laboratories

LinkedIn
2022-3 - 2023-6 · 1 yr 4 mos

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.

Guerbet

Manager Quality Control

Guerbet

LinkedIn
2018-5 - 2022-1 · 3 yrs 9 mos

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.

Guerbet

Quality Control Supervisor

Guerbet

LinkedIn
2015-12 - 2018-5 · 2 yrs 6 mos

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.

Mallinckrodt Pharmaceuticals

Quality Control Supervisor

Mallinckrodt Pharmaceuticals

LinkedIn
2013-7 - 2015-12 · 2 yrs 6 mos

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.

Covidien (Medtronic Minimally Invasive Therapies Group)

Quality Control Supervisor

Covidien (Medtronic Minimally Invasive Therapies Group)

LinkedIn
2012-2 - 2013-7 · 1 yr 6 mos

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.

Public Health Agency of Canada | Agence de la santé publique du Canada

Program Support Clerck

Public Health Agency of Canada | Agence de la santé publique du Canada

LinkedIn
2011-12 - 2012-2 · 3 mos

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.

Statistics Canada | Statistique Canada

Crew Leader - Census 2011

Statistics Canada | Statistique Canada

LinkedIn
2011-3 - 2011-8 · 6 mos

- 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

LAB Research

Director of Laboratories

LAB Research

2009 - 2010 · 1 yr

- 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

LAB Research

Director, Analytical Services

LAB Research

2006 - 2009 · 3 yrs

- 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.

ITR Laboratories Canada Inc.

Manager, Analytical

ITR Laboratories Canada Inc.

LinkedIn
2006 - 2006

- 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.

Anapharm

Director, Bioanalytical Sector, Bioanalytical Division

Anapharm

2001 - 2006 · 5 yrs

- 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.

Anapharm

Assitant-Director, Bioanalytical Division

Anapharm

1999 - 2001 · 2 yrs

- 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.

Anapharm

Project Manager, Bioanalytical Division

Anapharm

1998 - 1999 · 1 yr

- 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

MDS Pharma Services

Project Manager, LC/MS Department

MDS Pharma Services

LinkedIn
1994 - 1998 · 4 yrs

- 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.

Education

Université de Montréal

Université de Montréal

LinkedIn

Biochemistry

1980 - 1983 · 3 yrs

Denis Haché's Contact Information

Email

******@***.com

Phone

(**) *** ****

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