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Biologic Product Development Lead (h/f)

Ref 1226204

Geactualiseerd op 03 augustus 2020 via EXPERIS BELGIUM

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What are your responsibilities? As Biologic Product Development Lead, you are in charge to Initiates, directs and executes scientific research for innovation and process improvements; Responsible for the site Drug Product Development: Manage formulation development and improvement following Quality by Design approach and according to ICH Q8 regulation; Lead Failure Mode and Effect Analysis (FMEA) for the drug product formulation, fill and finish process; Be responsible of the compatibility studies with the manufacturing process materials, including tubing, bags, filters and final container closure; Knowledge and execution of matrix design for experiments as a part of defining process operating windows and design space; Build and maintain vendor relationships; Host technical workshops or meetings for process development groups; Acts as the technical lead for client development projects, communicates project status internally and externally, and effectively provides technical explanation/rationalization; Critically analyzes complex data, interprets and integrates experimental results with project objectives; Writes complex procedural SOPs, and reports; Accurately reviews batch records and other data, ensuring consistency; Expert knowledge of scale up principles with respect to formulation, fill & finish; Troubleshoot and problem solve in order to initiate and execute/monitor corrective actions; Performs lab overview for client tours and internal clients. Be the site SME (Subject Matter Expert) for biological drug product development and support the site transition towards biological drug manufacturing: Define and follow the implementation of the needed laboratory area and equipment to perform biological drug product formulation development, drug product process development and scale-ups; Collaborate with universities / research centers to ensure up-to-date knowledge of biological drug product development and manufacturing; According to increasing customers' demand,...
  • Etudes, recherche et développement / Recherche fondamentale et appliquée

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Naam van de werkgever
Mr Belgium Stepstone

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Opgelet! Het is niet nodig om Actiris te contacteren voor deze werkaanbieding. De vacature werd opgesteld door de werkgever. Actiris is niet verantwoordelijk voor de inhoud ervan en eventuele inbreuken tegen de wetgeving. Toch een opmerking over deze werkaanbieding? Aarzel dan niet om Actiris in te lichten.