MSAT Scientist

HIPRA es una empresa farmacéutica y biotecnológica enfocada en la prevención y diagnóstico para salud animal y humana, con una amplia gama de vacunas altamente innovadoras y un avanzado servicio de diagnóstico.  

Tiene una sólida presencia internacional en más de 40 países con filiales propias, 11 centros de diagnóstico y 6 plantas de producción ubicadas estratégicamente en Europa (España) y América (Brasil).  

La investigación y el desarrollo constituyen el núcleo de su conocimiento. HIPRA dedica el 15% de su facturación anual a actividades de I+D que se concentran en la creación y aplicación de los últimos avances científicos para el desarrollo de vacunas innovadoras de la más alta calidad. Para darle un valor añadido a su experiencia en vacunación, la empresa también desarrolla dispositivos médicos y servicios de trazabilidad. 

We are looking for a MSAT Scientist to join the new MSAT Team in the Operations area in the Human Health division. 

The MSAT Scientist will support the successful transfer, implementation, monitoring, and lifecycle management of Drug Substance and Drug Product manufacturing processes within the MSAT organization. This role will contribute to technology transfer activities from Process Development into GMP Manufacturing, as well as support external customer projects in a CDMO environment.

Responsibilities:

Technology Transfer & Process Support

• Support the planning, execution, and documentation of technology transfer activities for:
• Drug Substance processes (cell culture and purification)
• Drug Product processes (formulation and fill-finish)
• Participate in process scale-up activities, engineering batches, demonstration batches, and PPQ preparation.
• Collaborate with Manufacturing teams to ensure successful process implementation and operational readiness.
• Support the preparation and review of transfer documentation including:
• MSAT Plans
• Risk Assessments / FMEA
• Gap Analyses
• Comparability Assessments
• MSAT Reports
• Assist in ensuring traceability and data integrity of transfer-related documentation and process data.
• Support process monitoring activities during GMP manufacturing campaigns.

Process Monitoring & Lifecycle Management

• Support continuous process verification (CPV) activities and process trending.
• Analyze process performance data to identify trends, variability, and improvement opportunities.
• Contribute to process knowledge management and maintenance of process monitoring dashboards.
• Participate in process investigations, root cause analysis, and CAPA definition related to process deviations or atypical events.
• Support change control activities related to process improvements or manufacturing changes.
• Contribute to the continuous improvement of process control strategies in collaboration with cross-functional teams.

Cross-Functional Collaboration

• Work closely with Process Development, Manufacturing, QA, QC, Regulatory Affairs, Validation, and Engineering teams to support transfer readiness and execution.
• Support technical training and knowledge transfer activities for Manufacturing and operational teams.
• Participate in technical meetings and project discussions for internal programs and CDMO client projects.
• Collaborate with Analytical Development and QC teams to ensure analytical readiness for transfer and validation activities.
• Provide scientific and technical support during manufacturing troubleshooting activities.

GMP Compliance & Documentation

• Ensure all activities are performed in compliance with GMP requirements and internal quality procedures.
• Support deviation investigations, change controls, and CAPA implementation related to MSAT activities.
• Contribute to regulatory documentation and CMC sections related to manufacturing process transfers and validation.
• Participate in audits and inspections as SME or technical support representative when required.
• Maintain accurate and compliant technical documentation and records.

Requirements:

Qualifications & Experience

• MSc or PhD in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline.
• Typically over 2 years of experience in the biopharmaceutical industry within:
• MSAT / MS&T
• Process Development
• GMP Manufacturing
• Technology Transfer
• Experience with biologics manufacturing processes, including upstream and/or downstream processing.

HIPRA ofrece igualdad de oportunidades a todos sus trabajadores y trabajadoras.
Todos los/las solicitantes que reúnan los requisitos serán considerados para el puesto a cubrir, sin tener en cuenta el género, la raza, la nacionalidad, la condición de discapacidad o de edad.
Todas las decisiones de contratación se toman en base a los méritos, la competencia y las necesidades de la empresa.