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-motivated and able to motivate a team. Ability to work in a fast-paced environment and manage multiple competing demands.

We offer permanent contracts to become part of a biopharmaceutical company in full expansion.

Benefits

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- Life and accident insurance.

- Free company canteen.

- Free online training platform.

- Free online library. xhfqzwm

- Platform for social, physical and emotional well-being.

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📌 Msat Dp Technician (León)
🏢 Mabxience
📍 León