description du poste

Brabant Wallon – Contracting Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval. Define and select drug product manufacturing processes and parameters for clinical manufacture. Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organizations, as part of a project team. Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc). Capture and analyze critical manufacturing process data for process understanding and process characterization. Perform process risk assessments. Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products). Define the investigational medicine product preparation process in clinical trials. Provide support to ensure timely manufacture of stability and clinical DP batches. Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the company quality system, cGMP and latest regulatory requirements. Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities. Provide support in investigations of deviations and complaints related to DP quality. Support knowledge transfer from late phase development to commercial for validated DP processes. Contribute to develop the ways of working in the department. Scientific Master's Degree Minimum 3-5 years experience in sterile liquid drug product development and/or manufacturing within the pharmaceutical industry Fluent in French and English Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) Excellent communication, negotiation and team player skills Autonomous with good problem solving skills Investigation failure, process improvement, waste reduction, cost reduction Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage Knowledge in regulatory requirement is an advantage Understanding of biologicals drug product manufacturing process and scale-up is an advantage. Jefferson Wells offers you a permanent contra... Pharmaceuticals, Execution, Documentation, Communication, Risk Analysis, Protocols, Waste Reduction, Knowledge Transfer, Manufacturing, Data analysis, Quality systems, Validation, French language, Transfer, Projects, Write-up, Investigations, Investigations, Development, Manufacturing, Data Processing, Process Development, Process Development, Design, VOS, Medicine, Optimization, Medication, Compatibility, Problem Management, cGMP, Cost Reduction, Clinical Research, Syringes, Negotiation, Product Development, Toxicology, Characterization, Science, CMC, Filling, Briefing Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!

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