From Mabxience, a company specialized in the development and manufacturing of biosimilar medicines, we incorporated an MSAT DP Technician for our plant in León (Spain). Responsibilities * Technology transfer, implementation and validation of the drug product (DP) manufacturing processes in Fill&Finish; CMOs. * Technical communication with Fill&Finish; CMOs. * Implementation and optimization of DP manufacturing for technical and clinical GMP batches. * Development of the DP process carried out together with mAbxience R&D; department, including process FMEA and risk assessment, process development and process characterisation studies. * Process validation plan and report and control strategy definition. * Generation of documents needed for DP manufacturing and validation at CMO, such as: * Tech transfer protocols and reports. 1. Process descriptions. 2. Bill of materials. 3. Manufaturing Batch Records. 4. Sampling plans. 5. Process validation protocols and reports. * Review of manufacturing campaign data, trend monitoring and corresponding reports.



* Provide scientific support in the resolution of deviations and non[1]conformities. * Generation of documents with regulatory impact or those included in CTAs or regulatory files. * Support in internal, partner and regulatory authorities audits related with DP manufacturing activities. Requirements and personal skills * Education: University studies linked to biological or chemical sciences. * Languages: Intermediate to high level English (fluency is an asset). * Experience (years/area): At least 2 years of experience in F&F; operations in OP, R&D;, MSAT with knowledge of aseptic filling process development and tech transfer. * Specific Knowledge: Experience in GMP environment, knowledge in FDA is a plus. * Travels: Availability to travel. * Personal skills: 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 m

📌 MSAT DP Technician (León)
🏢 Mabxience
📍 León