Associate Director, Molecular Biology

Job description

Nombre del sítio: Belgium-Wavre
Fecha de publicación: Feb 23 2024

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 (exclusively PCRs) 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 PCRs 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, 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.
·  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.

Si tiene una discapacidad y necesita asistencia durante el curso del proceso de selección, tendrá la oportunidad de hacernos saber qué asistencia específica necesita para hacer los arreglos adecuados.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

    

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