Development & Validation Supervisor

The Development & Validation Supervisor is responsible for coordinating development and validation activities and ensuring that the group’s objectives (schedule and quality) are met. He must act as a subject matter expert (SME) for the development and validation activities of both the company and of the customers. He must also act as a resource person for the scientists of the Development & Validation teams as well as with clients and project managers for the analytical aspects of the projects.

Responsibilities:

  • Supervise and manage the daily activities of the Development & Validation team
  • Monitor the progress of Development & Validation activities (internal and subcontracted to external laboratories) to achieve monthly objectives
  • Performance management and perform mid-year and year-end evaluations of the Development & Validation team
  • Establish the objectives of the Development & Validation team
  • Write, review and approve protocols and reports for validation / transfer / verification of methods
  • Update monthly D & V metrics
  • Act as a leader in solving problems in the laboratory and continuous improvement
  • Actively participate in OOS / OOT investigations
  • Participate in the training of D & V scientists and QC analysts on newly implemented methods
  • Track modifications and maintenance / validations of equipment (HPLC, GC, etc.)
  • Purchase, writing of PON and training on new equipment as needed

Skills and experience required:

  • Bachelor in Sciences (Chemistry, Biochemistry), or a discipline related
  • Minimum of 10 years of experience in development and validation of analytical methods in the pharmaceutical industry
  • Minimum of 3 years of experience in management
  • Knowledge of Canadian Good Manufacturing Practices (GMP) (Health Canada)
  • Knowledge of Pharmacopoeias (USP, Ph. Eur. and BP) and their applications within a laboratory
  • Good knowledge with the following techniques: HPLC (UPLC) et GC 
  • Good communication and problem solving skills
  • Bilingual (French and English)

Application for the position of Development & Validation Supervisor

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Fields identified with an asterisk (*) are mandatory.

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