Downstream Biomanufacturing Sciences Specialist
UCB · Braine-l'Alleud
Job description
About the role
UCB is seeking a Downstream Biomanufacturing Sciences Specialist to ensure peak efficiency of the clinical manufacturing area and compliance with HSE, GMP and technical requirements. The role supports preparation, execution, review and release of clinical campaigns across phases I‑III and cell bank production.
Key responsibilities
- Support lab‑to‑pilot scale process transfer for new products and campaigns.
- Create and maintain documentation such as master batch records, check‑lists and coaching sheets.
- Develop mid‑term production plans in collaboration with the manager.
- Provide on‑floor support, spot‑checks and coaching during manufacturing campaigns.
- Interpret raw data, define action plans and manage deviations, change control and CAPA timelines.
- Act as Project Lead for downstream activities, overseeing implementation, monitoring and documentation.
- Support tech‑transfer, process performance qualification and regulatory inspections.
Required profile
- Degree in a relevant scientific or engineering discipline.
- Experience in pilot or large‑scale pharmaceutical manufacturing within a GMP environment.
- Fluent in French and technical English.
Required skills
- Downstream processing knowledge.
- Equipment qualification and cleaning/process validation.
- Process transfer and scale‑up expertise.
- Deviation, change control and CAPA management.
- Regulatory inspection support.
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Published 1 dag geleden
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UCB
Braine-l'Alleud
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