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).

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Responsibilities

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- 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:

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- Tech transfer protocols and reports.
- Bill of materials.
- Sampling plans.
- 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

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- 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-motiv

📌 MSAT DP Technician (León)
🏢 Mabxience
📍 León