Clinical Assay Expert Scientist
il y a 1 mois
**Site Name**: Belgium-Wavre
**Posted Date**: Feb 5 2024
**Job purpose**:
To contribute to the implementation of experimental design and data interpretation required for assay development, validation, and maintenance of clinical assays to detect and quantify biomarkers.
**Your responsibilities**:
- You contribute to the implementation of the experimental design in the lab and the interpretation of analytical data in collaboration with the designated statisticians and senior scientists.
- You provide scientific and technical support for:
- Internal activities related to assay development and validation, assay maintenance, monitoring and troubleshooting of assay issues and risks, in collaboration with the clinical read-out laboratory. To facilitate the integration of new technology
- External laboratories for assay quality during development, assay transfer, validation, & testing phases.
- You ensure assay history files are properly maintained and assay analytical plans, raw data and statistical reports are stored in sustainable systems and tools.
- You are responsible for the operational and technical management of assays, supporting one or several vaccine projects with limited number of technologies in collaboration with the assay owner.
- Lab technicians, lab managers are functionally collaborating with you in agreement with relevant quality management systems and Vaccine CL&AP (Clinical Lab and assay portfolio) governance to:
- Implement assay development and validation plans
- Implement assay trouble shooting plans
- Perform assay maintenance (Critical reagents characterization, qualification, bridging)
- Monitor assay performance over time (QC charts, trending analysis, QC panels)
- Ensure clinical testing in accordance to agreed timelines and data release milestones
- Oversee data checks and data release
- You contribute to the improvement of assay quality and facilitate implementation of new technologies.
- You provide technical support to projects and to the cost effectiveness of Vaccine CL&AP.
- You contribute to the development of expertise, the implementation of improvements in clinical laboratory processes, of state-of-the-art or innovative solutions in assay technology within the operational platform while giving special attention to assay quality and testing performance.
- You ensure all activities under your responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations, and internal policies.
**_ Why you?_**
**Basic Qualifications**:
- We are looking for professionals with these required skills to achieve our goals:_
- PhD in sciences or equivalent acquired through professional experience (Biology, Microbiology, Immunology, Biotechnology, Pharmacy orientation).
- Solid experience (5 years +) in assay development, good Quality culture is key.
- Scientific expertise in Bacteriology and technology including automation.
- Good experience in statistics is an advantage.
- Good knowledge of analytical techniques.
- Experience in project management.
- Interest in laboratory work and lab management is an important aspect of this role.
- Fluent in spoken and written English & French scientifically/technically as well as conversational are a MUST.
**Preferred qualifications**:
- If _you _have the following characteristics, it would be a plus:_
- PhD in sciences or equivalent acquired through professional experience (Biology, Microbiology, Immunology, Biotechnology, Pharmacy orientation).
- Solid experience (5 years +) in assay development, good Quality culture is key.
- Scientific expertise in Bacteriology and technology including automation.
- Good experience in statistics is an advantage.
- Good knowledge of analytical techniques.
- Experience in project management.
- Interest in laboratory work and lab management is an important aspect of this role.
- Fluent in spoken and written English scientifically/technically as well as conversational are a MUST.
- Being able to communicate in French or willing to learn are a plus.
Li-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
**Why Us?**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense
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