Senior Scientist Molecular Biology

le contenu du travail

Site Name: Belgium-Wavre

Posted Date: Sep 7 2021

Job purpose: You are the scientific and strategic lead in the development and maintenance of clinical assays to detect and quantify biomarkers. As assay owner, is responsible for the whole life cycle management of clinical assays including the design, development, validation, maintenance, monitoring and trouble shooting.

Key Responsibilities

• Lead the strategy for the technical development and validation of clinical assays used in one/several clinical trials.
• Act as assay owner:
• Ensuring assay performance fits its intended use by writing and reviewing the assay target profile.
• Being principal author and controlling assay development, assay qualification, assay validation plans and reports in agreement with quality by design principles and fulfill requirements from regulatory authorities. Write and review regularly assay summaries and procedures (SOPs).
• Being principal author of regulatory documents related to clinical laboratory assays
• Developing and controlling the assay maintenance and monitoring plans
• Developing and controlling qualification critical reagent plans
• Transferring assay inside/outside of GSK
• Performing assay troubleshooting and controlled assay continuous improvement
• Writing publications on his/her assay when appropriate
• Ensure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies.
• Provide support to the CLSL:
• For the definition of the assay target profile in agreement with the assay intended use in clinical endpoints
• for the development of documents for INDs, regulatory submissions, response to questions from regulatory authorities during submission, inspections
• for the review of the study design and protocol and discussion of study data
• Ensure assay milestones are appropriately planed and communicated to project stakeholders at Project-related CONSO team. Ensure oversight of encoding of activities, resources and budgets in finance management tools.
• Act as spokesperson as the Assay 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 Leader ...).
• Supervise continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions and cross-functional team efforts.
• Participate to CLS and R&D knowledge management in the field of expertise:
• Provide support related to scientific and technical aspects of the assays to vaccine development/acquisition due diligence, Innovation Project Team. Provide support for the development and/or review of internal and external publications, documents and communications.
• Provide scientific coaching to lab managers and other CLS members.
• Participate in the follow up of collaborations with other teams/experts to share/gain scientific and technical expertise and for technology transfer inside (i.e. Preclinical, QC) and outside GSK Vaccines.
  

Why you?

Basic Qualifications

• Master in Science or pharmacy (Biology, Microbiology, Immunology, Technology, Pharmacy, Molecular Biology)
• 5 years experience in assay development
• Good Quality culture
• Scientific expertise in Biology and technology including automation
• Strong communication and interpersonal skills
• Fluent in French and English
  

Preferred Qualifications

• PhD in science or pharmacy
• Good experience in statistics is an advantage
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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