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Expert Scientist
3 months ago
Posted Date: Aug 2 2024
The Expert Scientist is expected to lead, design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site.
He/she will ensure state of the art analytical development for macromolecule testing (polysaccharides, proteins, virus like particles etc), in line with Quality by Design (QbD) principles in the area of:
Separation Sciences technologies (UHPLC, GC-FID/MS, Headspace-GC, LC-MS, capillary electrophoreses, content testing, impurities, identity testing, ...).
He will participate to experimental activities according to defined priorities and is responsible for the quality of data and presentation of results to external audience.
He/she may need to manage a team.
Key Responsibilities:
- Independently responsible for the conception, design, implementation of analytical methods and interpretation of scientific and technical data to support projects. Designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework.
- Functions effectively as a core team member on multiple concurrent project workstreams and established work processes. Solves complex problems through collaborations with others, taking a new perspective on existing solutions. Generates strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies.
- Authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages. Makes sound scientific/technical and business decisions based on a balance of data, analysis and experience.
- Prepares and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc). Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development.
- Benchmarks specific technologies in own functional area to bring technology to state of the art. Contributes to and drives strategy and technical development planning and accountability in the execution thereof
- Collaborates with and/or leads/manage scientific staff, provides guidance to new team members and acts as a resource for colleagues with less experience.
- Ensure execution of the function's risk assessment and escalate at relevant bodies. Participates to development of mitigation plans.
- Leads and implements the respect of the GxP / EHS / QA rules application. Ensure the GMP release testing and stability of all investigational phase I/II/III vaccines with respect to the timings and in compliance with the GMPs requirements. Participate to and lead the validation of analytical methods, and transfer of validated analytical methods from ARD group to commercial QC or other partners. Write validation/transfer protocols and reports.
- Communicates effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate technical board. Act as a voice and ambassador of its department at various governance bodies / meetings.
Why you ?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.
- 6+ Years of experience in design and execute scientific studies in support of technical programs and biopharma / vaccine development process.
- Experience in the analytical characterization of macromolecules in particular polysaccharides, glycoproteins and glycoconjugates.
- Experience in GMP lab.
- Authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Masters Degree or PhD.
- Experience in method qualification/validation and Good understanding of QbD.
- Experience in data analysis automation and/or Real time release testing would be a plus.
- Experience in technology transfer in QC environment. Must have the ability to work with cross-functional teams and communicate effectively.
- Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development.
- Makes sound scientific/technical and business decisions based on a balance of data, analysis and experience.
- Solves complex problems through collaborations with others, taking a new perspective on existing solutions.
- Ability to effectively work and perform within a team of dedicated scientists.
- Communicates effectively within TRD and with external stakeholders (in GSK: GIO, RDC, Quality, outside GSK: universities, CMOs, presenting at scientific conferences) and is able to defend scientific and technical decisions at the appropriate technical board.
- Has the ability to impact scientific and technical vision and strategy
#LI-GSK
Please visit GSK US Benefits Summary t o 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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