Scientist - In-Process Analytics Technical R&D
* Requisition ID: WD163130
* Position: Full-Time Regular
* Open date: Apr 15, 2018 12:04 PM
* Functional area: Science and Technology
* Required degrees: Not Indicated
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The In-Process-Analytics Scientist, Drug Substance Belgium will work in a team of experts that supports Drug Substance process development for all vaccine projects (antigens) under the responsibility of the Belgian Technical R&D (TRD) Drug Substance organizations, Cell & Viral Drug Substance (CVDS) and Microbial Drug Substance (MDS).
The scope of the Belgian in-process-analytics organization is three-fold:
1. Develop fit-for-purpose methods/assays supporting process development, aimed to enable process design selection & process evaluation/ characterization.
2. Build novel and improve existing in-process-analytical capabilities of the organization for vaccine development in line with QbD principles and allowing deeper and broader understanding of the interphase & interplay between product and process
3. Support routine analyses of established in-process-methods as required by the vaccine development projects.
* You will develop In-Process- analytical methods/ tests for a wide variety of processes (fermentation, cell culture, viral production, purification, coupling) and antigens (recombinant, multimeric proteins, VLPs, glycoconjugates, viruses, etc…).
* You will develop methods for 1) antigen characterization and quantification, 2) product- and process-related impurities identification and quantification and 3) process performance characterization.
* You will participate in building next-generation in-process-analytical platforms for faster and earlier method development and better understanding of the antigens throughout the bio-process enabling to support process and product development more efficiently (time and quality).
* You will develop broad high-throughput analytical capabilities that will be crucial to further develop an integrated approach to high-throughput upstream, midstream and downstream Drug Substance development in dedicated and end-to-end high-throughput labs.
* You will develop strong interfaces with the Technical R&D Drug Product, Preclinical, Manufacturing Science and Technology, Clinical and commercial manufacturing organizations.
Why You?Basic qualifications:
* Ideally you have a PhD in bio-engineering, biochemistry, biotechnology, chemistry or equivalent.
* You have minimum 3 years experience in Bio-pharmaceuticals or Vaccines development.
* You have minimum 1 year experience in analytical development, in-process-analytics or equivalent
* You have an understanding of bioprocess development, Quality by Design, PAT, method qualification and assay (performance) characterization.
* You consistently apply sound scientific methodology, critical thinking and problem solving skills.
* You are comfortable and see the value of working in a multidisciplinary environment.
* Communication is one of your strengths
* You have an open and positive mindset
* You have an unstoppable drive for excellence
* You are fluent in English & French.
* You have an understanding of the industry trends and a good vision of in-process-analytics and its importance for next-generation bio-pharmaceutical and vaccine development.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Technical R&D Drug Substance organization, develops efficacious, safe and effective vaccine drug substance (antigen bulk) processes from small scale to commercial manufacturing scale. Through our activities & competencies, we generate the following:
* Information & knowledge that supports & enables to file and register new vaccines (antigen bulk manufacturing).
* Manufacturing processes & control strategies that are transferred to the clinical and commercial manufacturing organizations.
* Pilot-scale materials for non-clinical purposes (toxicology studies, stability studies, scale-down models, process reproducibility and robustness evaluation).
* Critical support to technical life cycle projects aimed at remediation, continuous process improvement, reliable supply and capacity increase to maintain existing assets at a competitive edge.
* Expert understanding of established and emerging biomanufacturing platforms down to the cellular and molecular level applying QbD approaches to engineer robust and cost-effective processes.
* Drug Substance reports into the Technical Research and Development organization within Vaccines R&D.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
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.