Clinical Assay Scientific Leader, Bacterial

Il y a 2 mois

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Oct 4 2024
**Job purpose**:
As the Scientific Leader and an expert in clinical assays within the Vaccines Clinical Laboratory & Assay portfolio (VxCL&AP) to be:

- The scientific and strategic lead in the development and maintenance of clinical assays to detect and quantify biomarkers.
- An assay owner, responsible for the whole life cycle management of clinical assays including the design, development, validation, maintenance, monitoring and troubleshooting.

**Your responsibilities**:

- You lead the strategy for the technical development and validation of clinical bacterial functional assays used in one/several clinical trials.
- You act as assay owner:
Ensuring assay performance fits its intended use by writing and reviewing the assay target profile.

Being the 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.

Writing and reviewing 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.
- You ensure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies.
- You provide support:
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.
- You supervise continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions and cross-functional team efforts.

Providing scientific coaching to Expert Scientist and lab managers.

**_ Why you?_**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Master’s degree in science or pharmacy with at least 7 years of expertise in the field.
Area of Specialization: Biology, Microbiology, Immunology.
- Fluency in written and spoken technical English, fluency in written and spoken French.
- Good knowledge of bacterial functional assays.
- Strong technical background in bio-analytical sciences.
- Quality mindset.
- Ability to work in a matrix organization; multi-cultural awareness is an asset.
- Change management: ability to lead and drive change.
- Strong influencing skills to engage and align operational teams.
- Excellent interpersonal skills with ability to lead cross functional teams.
- Effective communication skills to all levels in the organization, including presentation skills.
- Sense of urgency, flexibility and accountability.

**Preferred qualifications**:

- If _you _have the following characteristics, it would be a plus:_
- PhD degree in science or pharmacy.
- Expertise in laboratory operations, assay validation, GCLP is a plus.
- Skilled in automation assessment is a plus.

Li-GSK #GSKVaccines

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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