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Project Lead

3 months ago

Montreal, Quebec, Canada CellCarta Full time

About CellCarta
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry.

Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials.

The company operates globally with over 1,000 employees in its 11 facilities located in Canada, USA, Belgium, Australia, and China.


Summary of Position
The Project Lead will lead method validation, assay transfer and sample analysis studies based on approved driving documents

The project lead:
(a) Works in collaboration with the internal study teams to deliver quality data on time; (b) Plans required experiments based on the timelines, priorities and requirements, working in collaboration with Schedulers/Group Leaders/Managers; (c) Prepares and files associated documentation relevant to the studies as per appropriate regulatory requirements; (d) Submits study documents to QA and answers QA audit reports.

Responsibilities

  • Lead Method Validation and Sample Analysis studies;
  • Work in collaboration with the internal teams (scientists, laboratory, documentation review, quality assurance, data analysis, etc) to ensure study progress and timely delivery of quality data;
  • Monitor study readiness including driving documents, staff training / qualification, critical reagents and required reagents qualification /bridging and escalate gaps to management;
  • Track and monitor study sample status in realtime to ensure that they have been received, accessioned, tested, analyzed, reviewed, reported, destroyed (if applicable) or returned (if applicable), followup on any samples discrepancies;
  • Plan required experiments based on the timelines, priorities and requirements, working in collaboration with Schedulers/Group Leaders/Managers;
  • Follow up on, write and review deviations to ensure that they are captured, initiated, evaluated and closed in a timely manner;
  • Initiate and maintain the study binders throughout the study, submit studies to QA as required and answer QA reports;
  • Review method SOPs, as assigned;
  • Coach the laboratory staff through day to day interactions;
  • Provide recommendations and participate in quality and process improvements initiatives;
  • Foster communication and promote team building.

Education

  • Bachelor's degree in Biosciences or related field.

Required Experience and Skills

  • Knowledge of the GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) regulations;
  • 1 to 2 years of work experience in the biopharmaceutical industry;
  • Minimum of 35 years of equivalent experience;
  • Scientific knowledge in biochemistry and immunology an asset;
  • Capacity to multitask and work on multiple projects in parallel under strict time constraints and perform under pressure;
  • Excellent organizational skills and ability to prioritize;
  • High degree of initiative, sense of urgency and flexibility;
  • Ability to work independently as well as in a team environment;
  • Strong track record delivering projects on schedule and in scope;
  • Excellent problemsolving skills;
  • Meticulous with great attention to detail;
  • Experience coaching and training employees;


 Bilingual
  • Verbal and written in French and English an asset;
  • Knowledge of Microsoft Office programs, specifically Word and Excel.
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