Project Lead

Gosselies, Belgium
Full Time
Mid Level

Position Summary

Leads 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.

Responsabilities:

  • 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.

 

Profile:

  • 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.

All applicants are considered for all positions without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical or mental disability, medical condition, military or veteran status, genetic information, marital status, ethnicity, citizenship or immigration status or any other protected classification, in accordance with applicable federal, state, and local news. By completing this application you are seeking to join a team of hardworking professionals dedicated to consistently delivering outstanding service to our customers and contributing to the financial success of the organization, its clients, and its employees. Equal access to programs, services, and employment is available to all qualified persons.

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