Downstream Biomanufacturing Specialist - Clinical GMP

UCB

Eigenbrakel

Hybrid

EUR 85,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Hybrid work model
40% office time

Job summary

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.

Responsibilities

  • 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.

Skills

Downstream Biomanufacturing
Pilot/Scale-up experience
French language
Technical English

Education

Degree in a relevant scientific or engineering discipline

Tools

Equipment qualification
Cleaning validation
Process validation
GMP knowledge

Job description

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.

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