Associate Director, Molecular Biology

Jobinhalt

Site Name: Belgium-Wavre

Posted Date: Dec 13 2023

Job purpose:

As the Associate Director 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 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.

Writing publications on his/her assay when appropriate.

• You ensure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies.
• You provide support to the VxCL&AP LT:
  

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 ensure assay milestones are appropriately planned and communicated to project stakeholders at Project-related CONSO team.
• You ensure oversight of encoding of activities, resources and budgets in finance management tools.
• You act as spokesperson, as the Assay Scientific Expert on behalf of the VxCLAP organization to internal and external stakeholders (ie. Communication to outsourcing committee, Preclinical teams, collaboration with academic partners, Key Opinion Leader ...).
• You supervise continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions and cross-functional team efforts.
• You participate in VxCL&AP and R&D knowledge management in the field of expertise:
  

Providing support related to scientific and technical aspects of the assays to vaccine development / acquisition due diligence, Innovation Project Team.

Providing support for the development and/or review of internal and external publications, documents and communications.

Providing scientific coaching to Expert Scientist, lab managers and other VxCLAP members.

• You participe 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:

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, Technology, pharmacy; NGS expertise is good to have. High technical expertise level in the field is required.
• Fluency in written and spoken technical English, fluency in written and spoken French.
• Very good knowledge of real-time PCR
• Good knowledge in NGS assays management.
• 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:

Ifyou 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 and new technology assessment is a plus.
  

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 Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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