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 environm

📌 MSAT DP Technician (León)
🏢 Mabxience
📍 León