Project Lead

Location Belgium
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 11523
Published: about 1 month ago
A leading specialty CRO laboratory with expertise in immune monitoring, proteomics and biomarker research is hiring a Project Lead.

Responsibilities:
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.
  • 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.
Your Qualifications:
  • Master in Life Sciences or equivalent, preferably in Immunology.
  • Experience level can vary, however, a minimum of 2 years of experience in similar position is required.
  • 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 bio hazardous material, safety procedures and guidelines;
  • 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.).

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.