Downstream Biomanufacturing Specialist - Clinical GMP

UCB; Eigenbrakel; Hybride; EUR 85 000 - 120 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

40% office time

Résumé du poste

UCB in Belgium is seeking a Downstream Biomanufacturing Sciences Specialist to optimize clinical manufacturing in a GMP-compliant setting. You will help transition processes from lab to pilot scale, prepare documentation, and ensure timely, compliant campaigns across I, II, and III stages.

You will lead on-floor execution, provide GMP and scientific support, and collaborate across functions to meet quality and production targets while contributing to process improvements and tech transfers.

Qualifications

• Degree in a relevant scientific or engineering discipline.
• Experience with pilot or large-scale pharmaceutical manufacturing in a GMP environment.
• Strong knowledge in downstream processes.
• Knowledge of equipment qualification and cleaning/process validation.
• Fluent in French and technical English.

Responsabilités

• Support the process transfer from lab to pilot scale of new products or campaigns.
• Create documentation for process and process improvement (master batch record, check-list, coaching sheet).
• Elaborate mid-term production planning in collaboration with the Manager.
• Provide on-the-floor support and perform spot-checks during campaigns.
• Ensure operational goals are met on time and provide GMP and scientific support to the team.
• Interpret raw data, compile data sheets, and propose corrective actions as needed.
• Lead downstream projects from implementation to documentation and support tech transfer.
• Contribute to process performance qualification activities and scale-up to internal manufacturing and CMOs.
• Support regulatory inspections and participate in audits as a manufacturing representative.

Connaissances

Downstream Biomanufacturing

Pilot/Scale-up experience

French language

Technical English

Formation

Degree in a relevant scientific or engineering discipline

Outils

Equipment qualification

Cleaning validation

Process validation

GMP knowledge

Description du poste

UCB in Belgium is seeking a Downstream Biomanufacturing Sciences Specialist to optimize clinical manufacturing in a GMP-compliant setting. You will help transition processes from lab to pilot scale, prepare documentation, and ensure timely, compliant campaigns across I, II, and III stages.

You will lead on-floor execution, provide GMP and scientific support, and collaborate across functions to meet quality and production targets while contributing to process improvements and tech transfers.