Downstream Biomanufacturing Sciences Specialist

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

To strengthen our Clinical Manufacturing department, we are looking for a talented and motivated individual to fill the position of: Downstream Biomanufacturing Sciences Specialist, based in Braine-L'Alleud, Belgium.

About the role :

You will ensure that the manufacturing area is operating at peak efficiency and that product delivery complies with HSE (Health, Safety, Environment), GMP (Good Manufacturing Practice), and technical requirements by optimizing daily activities and performance across the department. You will actively and autonomously support the preparation, execution, review, and release of the clinical campaigns manufactured (technical & GMP batches phases, I, II, and III, as well as cell bank).

Who you’ll work with :

You will be assigned to the Bio Drug Substance Operations team, and you will engage in cross-functional interactions with other Process Specialists as well as with others.

What you’ll do :

• Support the process transfer from lab to pilot scale of the new products or campaigns.
• Create documentation for regular process and process improvement: master batch record, check-list, coaching sheet and additional instructions.
• Elaborate mid-term production planning and activities in close collaboration with the Manager.
• Perform routine (on-the-floor) support and spot-check during manufacturing campaigns.
• Assist and ensure that operational goals are met on a timely basis.
• Provide coaching/trainings and provide GMP & scientific support to team members.
• Check and interpret raw data generated and compiled the data sheet during the campaign and define or support action plan and corrections if needed.
• Understand the process and the need, collect feedback from Subject Matter Experts and in case of technical issue or discrepancies, suggest solutions to be able to meet the qualities requirements and the planning.
• Effective deviation and change control management as well as in the action plan follow-up (CAPA and action item) with respect of timelines.
• Act as Project Lead in Downstream field from implementation, monitoring and documentation point of view.
• Support tech transfer and process performance qualification activities by contributing, as Manufacturing Specialist, to process fit-gap assessments, supportive troubleshooting studies, process scale-up to internal manufacturing and CMO's.
• Support regulatory inspections and submissions by the participation and representation of production unit during audits.
• Downstream representative in global & cross-functional project teams by building relationships throughout and across departments to facilitate the sharing and gathering of information.
• Back-up to the team members.

Interested? For this role we’re looking for the following education, experience and skills :

• Degree in a relevant scientific or engineering discipline.
• Experience with pilot or large-scale pharmaceutical manufacturing, in a GMP environment.
• Strong knowledge in Downstream.
• Knowledge in equipment qualification & cleaning/process validation.
• Must be able to work on multiple simultaneous tasks with limited supervision.
• Fluent in French and technical English.

Are you ready to 'go beyond' to create value and make your mark for patients?

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.