ppFrom Mabxience, a company specialized in the development and manufacturing of biosimilar medicines, we incorporated an MSAT DP Technician for our plant in León (Spain). /p h3Responsibilities /h3 ul liTechnology transfer, implementation and validation of the drug product (DP) manufacturing processes in FillFinish CMOs. /li liTechnical communication with FillFinish CMOs. /li liImplementation and optimization of DP manufacturing for technical and clinical GMP batches. /li liDevelopment of the DP process carried out together with mAbxience RD department, including process FMEA and risk assessment, process development and process characterisation studies. /li liProcess validation plan and report and control strategy definition. /li liGeneration of documents needed for DP manufacturing and validation at CMO, such as: ul liTech transfer protocols and reports. /li liBill of materials. /li liSampling plans. /li liProcess validation protocols and reports. /li /ul /li liReview of manufacturing campaign data, trend monitoring and corresponding reports. /li liProvide scientific support in the resolution of deviations and non(1)conformities. /li liGeneration of documents with regulatory impact or those included in CTAs or regulatory files. /li liSupport in internal,



partner and regulatory authorities audits related with DP manufacturing activities. /li /ul h3Requirements and personal skills /h3 ul libEducation /b: University studies linked to biological or chemical sciences. /li libLanguages /b: Intermediate to high level English (fluency is an asset). /li libExperience (years/area) /b: At least 2 years of experience in FF operations in OP, RD, MSAT with knowledge of aseptic filling process development and tech transfer. /li libSpecific Knowledge /b: Experience in GMP environment, knowledge in FDA is a plus. /li libTravels /b: Availability to travel. /li libPersonal skills /b: Able to work independently, prioritize and meet project timelines, be strongly self-motivated and able to motivate a team. Ability to work in a fast-paced environment and manage multiple competing demands. /li /ul pWe offer permanent contracts to become part of a biopharmaceutical company in full expansion. /p h3Benefits /h3 ul liLife and accident insurance. /li liFree company canteen. /li liFree online training platform. /li liFree online library. /li liPlatform for social, physical and emotional well-being. /li /ul /p #J-18808-Ljbffr

📌 MSAT DP Technician (León)
🏢 Mabxience
📍 León