Raw Material Scientist, Jefferson Wells

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Plaats

Braine-L'Alleud
1420
Waals-Brabant
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-08-18

Online to:

2025-10-17
EUR 15.00 HOUR

Raw Material Scientist

Contracting – Brabant Wallon Generate risk assessments strategy for current raw materials and identify critical and key ones from a process, quality and supply point of view. Create and maintain related database and dashboard. Support the QbD initiative on raw material by writing supportive documentation (generate guidelines and templates) Define based on risk assessment mitigations and controls to be implemented in collaboration with appropriate teams (in production, release at supplier, shipment, storage, during usage). Support the introduction of new raw materials in close collaboration with process teams (supplier selection criteria at early stage, IPC/specifications definitions, shelf life definitions, ..) Improve raw materials usage in collaboration with process development and clinical manufacturing Create and lead satellite communities per expertise to facilitate exchanges, identify gaps and mitigations, build strategies on lessons learnt and successes to prepare future. Author & review technical documents including CMC regulatory sections, SOPs, technical position papers, & technical reports Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices. As a member of the DSPS team, the raw material scientist may work transversally across projects and groups in line with the needs of the business and as part of the CMC Development Sciences organization. > 4 years of experience in CMC development within the biopharmaceutical industry. Demonstrated ability to successfully co-ordinate project activities and manage meetings. Good knowledge of bioprocesses (Upstream/Downstream) with previous technical experience in Biologics or Gene therapy. Good interpersonal skills in order to communicate with and maintain fruitful working relationships with colleagues across departments and geographies, as well as external partners. Basic knowledge of regulatory guidelines, safety and q... Gene Therapy, Expertise, Documentation, Shipment, Risk Analysis, Science, Strategies, Business, Manufacturing, Biopharmaceuticals, Templates, Storage, Stage, Dashboard, Mitigation, Literary science, Introduction, Investigations, Projects, Technical Reports, Development, Project activities, Process Development, Writing, Biopharmaceuticals, Raw material, IPC, Coordination, Communication, Geography, VOS, Health & Safety, Satellite, Database, Best Practices, Production, Downstream, Peer support, Supplier Selection, CMC

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