Scientist Downstream
Il y a 4 mois
**Site Name**: Belgium-Rixensart
**Posted Date**: Sep 27 2024
**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).
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