Job Description
As a Scientist within the Vx CL&AP (Vaccines Clinical Laboratory and Assay Portfolio) department; the department which is responsible for the development of Clinical assay and clinical testing activities to support Vaccines development studies you will be supporting this department by using your scientific writing skills to support the cross-validation activities.
Tasks : Following the ICH guideline, write cross validation protocol for a specific assay
Deliverable 2 : Design manipulation for cross-validation
Translate the assay cross validation strategy into experimental design in the lab, analyze raw data, prepare material for data interpretation with the assay owner. You will :
- Translate the assay cross validation strategy into experimental design in the lab.
- Review and analyze raw data; ensure data quality.
- interpret analytical data and prepare material (e.g. summary table) for consolidation with the assay owner.
- Accountable for the day-to-day follow-up of transfer activities according to planning.
- Escalate any delay or anticipated delay to the assay owner.
Deliverable 3 : Oversight of lab activities for cross-validation. You will :
Work in collaboration with Lab manager to oversight lab activities.ensure all activities under your responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations, and internal policies with the support of the assay owner.Oversight day to day manipulation in lab according to protocol and transfer planningEnsure trouble shooting in the lab in case of assay issue.Ensure assay stability monitoring.Identify and promptly escalate assay related risk or issue that may arise.Deliverable 4 : Review of Statistical Analysis Report where you will :
Discuss with the designated statisticians to identify the appropriate statistical analyses to be performed.Provide consolidated material to the statistician.Review the statistical report to ensure consistency of the conclusion according to the analysis objective.Deliverable 5 : Redaction of cross validation report where you will :
Write the cross-validation report under the supervision of the assay owner.Ensure appropriate storage and traceability of all assay related documentation throughout the entire process.Qualifications
A Master’s degree in a scientific field (Biology, chemistry, etc)A first experience in laboratory (microbiology, ELISA, PCR) in a pharmaceutical environment.An experience in a regulated environment (GCLP)Fluent communication skills in French and English are mandatory.Additional Information
A full-time (40hours / week) Monday – Friday job.A Permanent contract with flexible working hours.Work in a fast-growing international organization.Meal Vouchers 8 Euro / Working Day.Eco-Cheques + / - 250 Euro / Year.DKV Hospitalization insurance.Additional 12 ADV days per year.A company well-being program targeting both mental and physical well-being