Clinical Assay Expert Scientist
il y a 3 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Feb 14 2023
**Job purpose**:
To contribute to the design of experiments and data interpretation required for assay development, validation and maintenance of clinical assays to detect and quantify biomarkers.
**Your responsibilities**:
Under the leadership of a senior scientist your responsibilities will include:
- You prepare/write analytical plans for assay development, qualification and validation steps.
- You review and interpret analytical data in collaboration with the designated statisticians.
- You ensure the scientific and technical oversight of:
- 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.
- External laboratories for assay quality during development, validation, & testing phases.
- Execution of assay analytical plans by the external partner.
- You ensure assay history files are properly developed and maintained and assay analytical plans, raw data and statistical reports are stored in sustainable systems and tools
- You develop team capabilities and the introduction of new concepts to continuously improve assay quality, technical support to projects and cost effectiveness of CLS.
- You develop and maintain expertise in assay technologies to support the technological improvement and innovation in the operational platform with specific attention given 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.
- You act as spokesperson, as a technology Scientific Expert on behalf of the CLS organization to internal and external stakeholders (ie. Communication to outsourcing committee, Preclinical teams, collaboration with academic partners, Key Opinion Leaders,...).
- You supporte the implementation of continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions and cross-functional team efforts.
- You participate in CLS and R&D knowledge management in the field of expertise.
**_ 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 scientifically/technically as well as conversational are a MUST.
- Being able to communicate in French or willing to learn are a plus.
**Preferred qualifications**:
- If _you _have the following characteristics it would be a plus:_
- Relevant experience in data interpretation, statistical approaches, etc.
- Ability to influence and negotiate at all levels of the organization in order to meet objective or deliverable.
- Good stakeholder management and excellent communication skills are necessary to meet needed mindset and behavioral changes that will be required by the business.
- Team spirit, autonomy, scientific rigor, analytical mindset & strong networking skills.
- Good organization skills (day-to-day operations and lab management).
- Ability to drive change, flexible thinking and having an open mind to imbed change.
- Continuous scientific curiosity.
Li-GSK
**_Why GSK?_**:
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.
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 t
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