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.
- 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.).
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.