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.

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

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

Life and accident insurance.

Free company canteen.

Free online training platform.

Free online library.

Platform for social, physical and emotional well-being.

📌 MSAT DP Technician (Madrid)
🏢 Mabxience
📍 Madrid