MSAT DP Technician

mAbxience; León; Presencial; EUR 42.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Life and accident insurance

Free company canteen

Free online training platform

Free online library

Well-being platform

Descripción de la vacante

Mabxience is seeking an MSAT DP Technician for the León, Spain plant to support technology transfer, validation and optimization of drug product manufacturing processes in Fill & Finish CMOs.

Responsibilities include collaboration with R&D, development of process validation plans, generation of regulatory documents, and provision of technical support during audits. The role requires at least 2 years in F&F operations and a background in biological or chemical sciences.

Formación

• Education: University studies in biological or chemical sciences.
• Languages: Intermediate to high English; fluency is an asset.

Responsabilidades

• Technology transfer and validation of DP manufacturing processes in Fill & Finish CMOs.
• Technical communication with Fill & Finish CMOs.
• Implementation and optimization of DP manufacturing for GMP batches.
• Development of DP process with R&D incl. FMEA and risk assessment.
• Process validation plan, reports and control strategy definition.
• Generation of DP manufacturing and validation documents for CMO.
• Review of manufacturing campaign data and trend reports.
• Support in audits and regulatory activities regarding DP manufacturing.

Conocimientos

Independent work

Prioritization

Motivation

Adaptability

English proficiency

Educación

Biology or Chemistry degree

Descripción del empleo

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.