Job purpose:

The coordinator Monography and projects (Stability) is an individual contributor capable of independently executing writing assignments involving a thorough understanding of analytical R&D processes and procedures. The candidate would be expected to support the control strategy and the stability process and related documents in collaboration with Analytical Product Leaders, ARD technical experts, TRD experts, commercial QC, QA and Regulatory Affairs.

The Coordinator has the ability to plan and prioritize with minimal supervision.

Your responsibilities:

• You support the definition of the control strategy for all Ph1 to Ph3 projects for GMP, Toxicological, biologicals standard, Reproducibility, Engineering, and in-process batches and in agreement with appropriate analytical project leader (APL) and key stakeholder (RA/QA/producer).
• You support the Stability process for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
• You support the stability intermediate or final report, trending analysis, consistency table, stability plan modification with Analytical Product Leaders, ARD technical experts, External Third Parties and Quality.
• You support Analytical Product Leaders and ensures quality assurance for specific documentation for regulatory purpose (Stability reports).
• You manage Unplanned events in line with stability process, sample dispatching or SAP master data process.
• You ensure the consistency and quality level of all documents that are issued requiring minimal quality check and rework. Ensure quality assurance for all written materials within scope
• You demonstrate skills in effectively managing assignments (including multiple priorities and responsibilities) and assure assigned milestones are achieved within the established time frames.
• You have the ability to work within a complex matrix structure (with Analytical Product Leader, Technical Development Leader, Platform heads, technical experts) and drive the process. Establish network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• MS OR BS with 5+ years of experience.
• Degree in Chemistry/Biochemistry/Biology.
• Possesses knowledge of internal processes/procedures.
• Possess general computer literacy.
• Proficiency in written and spoken English.
• Proficiency in written and spoken French.

Preferred qualifications:

If you have the following characteristics it would be a plus:

• Written and spoken local language.
• Sound scientific methodology, critical thinking and problem-solving skills.
• Ability to integrate and work in a team.
• Demonstrated ability to be proactive and take initiative
• Flexible, and easily adapt to new/unexpected situations.

#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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