Site Name: Belgium-Rixensart Posted Date: Jun 27 2024 Job Purpose The Head of In-Process-Analytics, Drug Substance Belgium will lead a team of experts that supports Drug Substance process development for all vaccine projects (antigens) under the responsibility of the Belgian TRD Drug Substance organizations. The selected head of In-Process-Analytics will report to the Head of the Belgian Early development and In-process analytics group. The Head of In-Process-Analytics Drug Substance Belgium will lead a team of experts dedicated to supporting Drug Substance process development across various vaccines programs. This position is crucial for maintaining the highest level of analytical rigor and efficiency within the Belgian TRD Drug Substance organization. The successful candidate will drive the advancement of in-process analytics within the organization, ensuring alignment with QbD principles and fostering a deep understanding of the interface between product and process. The scope of the Belgian In-Process Analytics organization is three-fold: 1. Develop Fit-for-Purpose Methods: Create tailored methods and assays that support early process development, enabling precise process design selection and thorough process evaluation and characterization. 2. Enhance In-Process-Analytical Capabilities: Build, refine, and scale the organization’s in-process-analytical capabilities for vaccine development in alignment with QbD principles, fostering a deeper and broader understanding of the interactions and interfaces between product and process. 3. Support and Organize Routine Analyses: Facilitate the transfer and organization of routine analyses for established in-process methods applicable to the Belgian Microbial Drug Substance and Cell and Viral Drug Substance development units, ensuring readiness for advanced projects as dictated by vaccine development needs. Key Responsibilities Team Leadership and Development: Lead and develop your team towards achieving excellence in in-process analytics, enabling Drug Substance and the broader TRD organization to reduce time-to-market, improve profitability, and enhance product robustness. Innovative Analytical Methods: Develop in-process analytical methods using advanced technological platforms (e.g., immunoassays, HPLC, cell-based assays using FACS, Mass Spectrometry, …) for a wide array of processes including fermentation, cell culture, viral production, purification, and antigen generation (e.g., recombinant proteins, VLPs, glycoproteins, viruses, mRNA). Comprehensive Analysis: Utilize analytical methods for (1) antigen characterization and quantification, (2) product and process-related impurities identification and quantification, and (3) process performance characterization. Analytical Platform Development: Develop and consolidate in-process analytical platforms for faster and deeper understanding of antigens throughout development, supporting process and product development more efficiently. High-Throughput Capabilities: Develop high-throughput analytical capabilities essential for integrated support in high-throughput upstream, midstream, and downstream Drug Substance development in both dedicated and large-scale high-throughput labs. Collaboration and Innovation: Collaborate closely with your team and PAT subject matter experts in the Drug Substance network to enhance process control and monitoring. Work with internal and external industry trends to ensure the latest practices are integrated into your workflows. Partnerships and Networking: Establish and maintain key partnerships with the analytical R&D organization to leverage specialized expertise and capabilities, ensuring the highest standards in various development projects within the most effective timeframes. Engage in Stakeholder Collaboration: Build strong relationships with in-process analytics groups within the Global DS organization to share knowledge, stimulate innovation, and drive the adoption of advanced technologies across the network. Holistic Approach to Development: Align with the Technical R&D Drug Product, Preclinical, Manufacturing Science and Technology, and Commercial Manufacturing organizations to ensure cohesive and comprehensive in-process analytical strategies. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: You have at minimum a master’s degree in bioengineering, biochemistry, biotechnology, chemistry, or a related field. You have at least 5-8 years of experience in Biopharmaceuticals or Vaccines development. You possess a minimum of 3-5 years’ experience in analytical development, in-process analytics, or a related area. You have a thorough 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 thrive in a multidisciplinary environment, adept at working with various technologies (e.g., immunoassays, HPLC, LC-MS, cell-based assays). You excel at leading a team, developing people, setting direction, focusing on priorities, and inspiring the organization is what you like and are good at. Preferred Qualifications: If you have the following characteristics, it would be a plus: Your interpersonal skills allow you to engage effectively with stakeholders both inside and outside your organization. Communication is one of your strengths. You have an unstoppable drive for excellence. Speaking French is an asset 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). 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