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Project Lead (H/F/X)

May 25th 2021

CellCarta is an international contract research organisation (CRO) based in Montreal (Canada) offering analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical studies

Mission Description

Key Responsibilities

  • Management of method validation, assay transfer and sample analysis studies;
  • Prepares and/or reviews worksheets related to studies;
  • Ensures personnel are trained and training appropriately documented;
  • Ensures high level documents are signed and acknowledged by personnel involved in the study;
  • Ensures study binders are up to date;
  • Follows up on assigned study inventory and sample manifest;
  • Follows up on deviations;
  • Follows up on QC review and ensures it is performed in a timely fashion;
  • Prepares and/or reviews of data tabulation and study related documents;
  • Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates ; coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
  • Submits studies to QA and answers to QA reports;
  • Schedules experiments based on the timelines, priorities and requirements;
  • Writes and reviews method SOP/CSP;
  • Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies.

Other Responsibilities

  • Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
  • Performs other duties as assigned.

Special Conditions of the Current Position

  • Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
  • Employee is personally responsible for following Health and Safety guidelines/instructions.
  • This position can involve evening and/or week-end work.

Candidate profile

Education

  • Master in Life Sciences or equivalent, preferably in Immunology.

Experience

  • Experience level can vary, however, a minimum of 2 years of experience in similar position is required.

Knowledge Requirements

  • Strong scientific knowledge;
  • Good knowledge of clinical study conduct;
  • Good knowledge and understanding of bioanalytical method validation guidelines and requirements;
  • Knowledge and understanding of GLP, GCLP regulations to carry out GLP studies;
  • Knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines;

Skill Requirements

  • Strong experience in working in a normative environment;
  • Strong skills in English writing procedures and protocols;
  • Strong quality mindset;
  • Strong cross-functional communication skills.
  • Capable of producing document of high quality;
  • Rigorous and autonomous in the conduct of their work;
  • Demonstrated time and priority management skills;
  • Effective organizational skills and flexibility;
  • Ability to lead a study (e.g. documentation, reagents, schedule, etc.).

Offer

For more information please contact to CellCarta

Contact Details

For more information please contact to CellCarta