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Scientist
Il y a 2 mois
Job Description
As a Scientist within the Vx CL&AP (Vaccines Clinical Laboratory and Assay Portfolio) department, you will be supporting the development of Clinical assay and clinical testing activities to aid Vaccines development studies using your scientific writing skills for cross-validation activities.
Tasks:
- Write cross validation protocol for a specific assay following ICH guidelines.
Deliverable 2: Design manipulation for cross-validation
Translate the assay cross validation strategy into experimental design, analyze raw data, and prepare material for data interpretation with the assay owner. Responsibilities include:
- Translate the assay strategy into experimental design.
- Review and analyze raw data to ensure quality.
- Interpret analytical data and prepare material for consolidation.
- Accountable for daily follow-up of transfer activities.
- Escalate any delays to the assay owner.
Deliverable 3: Oversight of lab activities for cross-validation.
- Collaborate with Lab manager for oversight.
- Ensure activities adhere to Quality Assurance (QA) guidelines.
- Oversight of manipulation in lab according to protocol and planning.
- Troubleshoot assay issues.
- Monitor assay stability and escalate risks promptly.
Deliverable 4: Review of Statistical Analysis Report.
- Discuss with statisticians for appropriate analyses.
- Provide material to the statistician and review report consistency.
Deliverable 5: Redaction of cross validation report.
- Write the report supervised by the assay owner.
- Ensure storage and traceability of all documentation.
Qualifications
- Master's degree in a scientific field (Biology, chemistry, etc).
- Experience in laboratory (microbiology, ELISA, PCR) within a pharmaceutical environment.
- Regulated environment experience (GCLP).
- Fluent in French and English.
Additional Information
- Full-time position (40 hours/week) Monday – Friday.
- Permanent contract with flexible hours.
- Fast-growing international organization.
- Meal Vouchers 8 Euro/Working Day.
- Eco-Cheques +/- 250 Euro/Year.
- DKV Hospitalization insurance.
- 12 ADV days per year.
- Well-being program targeting mental and physical health.
