Clinical Assay Expert Scientist, Bacterial Functional Assay

Job title:

Clinical Assay Expert Scientist, Bacterial Functional Assay

Company

GlaxoSmithKline

Job description

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 Biology 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 Biology 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 #GSKVaccinesIf 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Expected salary

Location

Waver, Waals Brabant

Job date

Sat, 29 Jun 2024 04:00:33 GMT

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