We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

Find out more:

Our approach to R&D.

You will be working with a novel, next generation approach to the development of vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.

The specialist Monography and projects (Stability) is an individual expert contributor capable of independently executing writing assignments involving a thorough understanding of analytical R&D processes and procedures. He/she would be expected to manage the stability process and related documents in collaboration with Analytical Product Leaders, ARD technical experts, TRD experts, commercial QC, QA and Regulatory Affairs.The specialist has the ability to plan and prioritize with minimal supervision.

Your responsibilities:

• Support the Stability process using a QbD approach, for clinical material at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.

• Manage the stability intermediate or final report, trending analysis, consistency table, stability plan modification, external and internal COA and stability usage decision in SAP with Analytical Product Leaders, ARD technical experts, External Third Parties and Quality.

• Support the definition of the product & stability analytical master plan 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).

• Ensure the consistency and quality level of stability documentation that is issued requiring quality check (QC).

• Support Analytical Product Leaders and ensures quality assurance for specific documentation for regulatory purpose (Stability reports).

• Manage Unplanned events or SOP updates in line with stability process.

• Support development of new IT tools to manage trending and stability results with statisticians, Tech, Regulatory and Analytical Product Leaders.

• Ensure the consistency and quality level of all documents that are issued requiring minimal quality check and rework. Ensures quality assurance for all written materials within scope and in line with internal or external procedures

• Demonstrate skills in effectively managing assignments (including multiple priorities and responsibilities) and assures assigned milestones are achieved within the established time frames.

• 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 with 3+ years of experience OR BS with 6+ years of experience.

• Degree in Chemistry/Biochemistry/Biology.

• GMP experience.
  

Preferred Qualifications:

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

• Knowledge of Stability processes/procedures.

• Experience in writing deviations, investigations, change controls, CAPA, protocols, and reports.

• 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.

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Why GSK?

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. 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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