Site Name: Belgium-Rixensart Posted Date: Sep 27 2024 As a Scientist specialized in downstream purification, you will join a team of experts dedicated to developing drug substance processes for new vaccine candidates, from Phase I to commercial launch. Additionally, you will engage in life cycle activities to improve processes within the commercial vaccine portfolio. The successful candidate will report to the Head of Development Unit 4 within the Microbial Drug Substance department in Belgium, part of the Global Drug Substance organization in Technical R&D (TRD). Your Responsibilities: Experimental Design and Execution: Support the downstream team by autonomously designing and conducting experiments in the lab (spending approximately 70% of your time in the lab and 30% on administrative tasks, including cross-functional scientific discussions). Implement the latest industry trends and state-of-the-art technologies to enhance current manufacturing processes, aiming for scalable, high-efficiency, robust, and cost-effective methods with a reduced footprint. Analytical Strategy: Collaborate with the In-Process Analytical organization to develop and implement IPA strategies and testing for downstream processes. Project Management: Demonstrate project management skills by performing timeline and resource planning, planning experimental protocols, and leading a team of technicians. Maintain a strong lab presence to ensure best practices, compliance with documentation, and adherence to EHS standards. Collaboration: Collaborate inside and outside Technical R&D. Ensure strong interfaces and knowledge sharing with Manufacturing Science and Technology, global supply chain team which are involved in the project. Collaborate with multidisciplinary team. Documentation: Write and review project reports, including process history files and process development reports. Quality by Design: Follow the Quality by Design approach to process development. Lead multi-disciplinary Technical Risk Assessments and ensure all documentation deliverables are met at each project stage gate. Team Development: Support the Development Unit Head in elevating the technical knowledge and best practices of the team, both within your unit and across other units in the department. Proactively promote initiatives. Scale-Up Coordination: Work closely with the Scale-up team during development stages to ensure smooth transitions across different project phases. Why You? Basic qualifications: Educational background: Master’s degree in bio-engineering, biochemistry, biotechnology, chemistry, or a related field. PhD is a plus. Experience: Initial experience in the purification of biological materials and/or manufacturing in the biopharma/biotech industry. Technical knowledge: Demonstrated expertise in chromatographic separation, tangential filtration, centrifugation, and other techniques typically associated with protein and/or polysaccharide separation. Demonstrated expertise in analytical methods associated with purification process monitoring. Technical interest: Deep interest in the technical aspects of the job and a willingness to participate actively on the shopfloor. Scientific Skills: Strong scientific methodology, critical thinking, and problem-solving abilities. Communication: Strong communication skills, both written and spoken in English, scientifically/technically as well as conversationally. Being able to communicate in French. Adaptability: Ability to work in a dynamic, multidisciplinary environment and embrace change positively. Proactivity: Demonstrated ability to be proactive, take initiative, and lead autonomously. Excellence: Imprinted with a desire for rigor, excellence, optimistic, and open-minded. Leadership: Motivated by process development from lab scale to manufacturing scale, with the ability to lead both in the lab and manage a small team of technicians. Preferred qualifications: Ideally 3-5 years or more experience in Vaccines Drug Substance development and/or manufacturing (Product & Process Expert or similar), particularly in protein purification and characterization. Strong understanding of clinical and commercial Manufacturing processes and manufacturing constraints. Strong understanding and knowledge of process industrialization methods. Strong understanding of the industry trends and a compelling vision of next-generation and vaccine and biopharmaceutical development and manufacturing. Understanding in continuous manufacturing, high throughput , big data, multivariate analysis, predictive analytics and modelling approaches. Why GSK?: Our Department: The TRD Drug Substance organization, develops efficacious, safe and effective vaccine drug substance (antigen bulk) processes from small scale to commercial manufacturing scale. The Drug Substance reports into the TRD organization within Vaccines R&D . 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 bio-manufacturing platforms down to the cellular and molecular level applying QbD approaches to engineer robust and cost-effective processes. #Li-GSK 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). 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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