Clinical Assay Principal Scientist

Site Name: Belgium-Wavre

Posted Date: Nov 20 2024

Job purpose: To contribute to the implementation of experimental design and data interpretation required for development, validation, and maintenance of clinical assays.

Your responsibilities:

- 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.
- You contribute to the implementation of the experimental design in the lab and the interpretation of analytical data in collaboration with the designated statisticians.
- You provide scientific and technical support for the definition of assay development, qualification, and validation plans.
- You perform scientific and technical oversight of:

- Internal activities related to assay development and qualification, assay maintenance, monitoring, and troubleshooting.
- External laboratories for assay quality during development, qualification, and testing phases. You are responsible for the writing of assay analytical plans and ensure plans are executed by the external partner. You manage the communication with the external partner.

- 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 collaborate with lab managers and lab technicians, in agreement with relevant quality management systems and Vaccine CL&AP (Clinical Lab and assay portfolio) governance to:

- Implement assay development, qualification and contribute to validation plans.
- Perform assay maintenance (Critical reagents characterization and qualification).
- Implement assay trouble shooting plans.
- Clinical testing in accordance to agreed timelines.
- 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 act as an expert in one or several specific matters related to clinical testing technologies such as lab automation, lab technologies, lab data management, lab documentation, external testing oversight.
- You present data in meetings within Vaccine CL&AP or in front of an external audience scientific (presentations, posters, communications).
- You act as spokesperson as a technology Scientific Expert on behalf of the Vaccine CL&AP organization to internal and external stakeholders.
- 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 Biology and technology including automation.
- Good experience in statistics is an advantage.
- Good knowledge of analytical techniques.
- Experience in project management.
- 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 Biology and technology including automation.
- Good experience in statistics is an advantage.
- Good knowledge of analytical techniques.
- Experience in project management.
- 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.

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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 GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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