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Biologic Product Development Lead (h/f)

Réf 1226204

Actualisé le 04 août 2020 par 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

Comment postuler ?

Nom de l'employeur
EXPERIS BELGIUM
Personne de contact
Mr Belgium Stepstone
Mode de présentation

postuler via le site Web

Website
http://www.stepstone.be/offres-d-emploi----1807958-inline.html?cid=Partner_ActirisExport
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