Associate Scientist, Immunogenicity

Site Name: USA - Pennsylvania - Upper Providence

Posted Date: Jun 20 2024

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

As an Associate Scientist in the Immunogenicity Team, you will be responsible for the validation and sample testing of anti-drug antibody (ADA) and neutralizing antibody (NAb) assays for use in clinical studies in alignment with therapeutic area partners. Data from this group informs patient safety and efficacy profiles of biotherapeutics in the GSK pipeline and helps clinical development teams make early and informed decisions for asset progression.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Responsible for validating bespoke immunogenicity assays to support clinical studies, delivery of robust, high quality data packages.

• Apply advanced immunological and analytical techniques to improve assay design and throughput including the use of automation where applicable.

• Independently provide sample analysis support for clinical studies by delivering high quality data packages working in a GLP/GCP compliant laboratory setting.

• Work and communicate effectively with the group and speak up when necessary.

• Perform experimental work using human serum samples in accordance with Human Biological Sample Management (HBSM), safety and data integrity guidelines.

• Author or contribute to Standard Operating Procedures (SOPs), Analytical Methods, Sample Analysis Reports and other technical documentation to a high scientific standard.

• Perform quality checks of data, electronic laboratory notebooks, and other documentation for self and peers.

• Proficient in the general functions of Watson LIMS for sample tracking and data analysis and electronic notebook for experimental documentation.

• Perform document archiving according to company archiving and retention policies.

• Maintain a clean, safe work environment. Perform routine laboratory equipment maintenance.

• Conduct study phase in accordance with all applicable laws and regulations including, but not limited to, Good Laboratory Practices (GLPs; 21 CFR Part 58) and departmental Standard Operating Procedures.

Basic Qualifications:

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

• BS in Biology, Biochemistry, Immunology or related discipline.
• 1 or more years of experience working in a pharmaceutical, biotechnology or CRO environment applying GLP regulations.

Preferred Qualification:

• MS in Biology, Biochemistry, Immunology, or related discipline

• Strong laboratory hands-on experience and theoretical understanding of clinical plate-based immunoassay validation and clinical study support using various immunoassay platforms (MSD /Singulex /Gyros) to support immunogenicity (ADA and NAb) endpoints.

• Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.

• Attention to detail, good communication and documentation skills will be expected.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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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