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 1000 employees in its 11 facilities located in Canada, USA, Belgium, Australia, and China.
The project Lead will lead method validation, assay transfer and sample analysis studies based on approved driving documents. Prepares and/or reviews experimental documentation for assigned studies. Prepares and/or fills associated documentation relevant to the studies as per appropriate SOP/CSP and applicable regulatory requirements. Writes and reviews method procedures (SOP/CSP). Responsible for binder submission to QA and answering of QA audit reports.
- 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;
- Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures.
The applicant must:
- 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.
- Master in Life Sciences or PhD in Immunology.
- Experience level can vary, however, a minimum of 2 years of experience in similar position is required.
- Strong knowledge in flow cytometry;
- 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.