Make your mark for patients.
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
To strengthen our new Gene Therapy (GT) Bioprocess Engineering Team , based in Braine-l’Alleud (Belgium) we are looking for a talented individual to fill the position of: Gene Therapy Bioprocess Engineer (DS or DP) .
The role involves definition of equipment and single-use assemblies user requirements as well as supporting design and qualification for all relevant clinical manufacturing steps with specific focus on DS and/or DP P rocess E quipment. This will be performed in close collaboration with the engineering-, qualification - and quality assurance departments.
Furthermore, technology transfer to-and from the GT Clinical Manufacturing are in scope. This involves process evaluation for facility fit, scale-up and mass balances as well as creation and review of process documentation such as risk assessments, process descriptions, summary reports submission sections and tech transfer protocols.
Finally process validation and continued process verification activities are supported in collaboration with the process development team.
More precisely, as a Gene Therapy Bioprocess Engineer , you r main responsibilities are:
Process transfer from development to DS/DP clinical/commercial manufacturing.
Act as Gene Therapy Bioprocess Engineering SME for facility and equipment design and qualification.
Integrate gene therapy bio-process engineering team to the site.
Design and qualify single-use systems such as liquid transfer assemblies, manifolds and bags.
Design and qualify DS/DP process equipment. Generation of risk assessments and user specifications for manufacturing systems and single-use materials.
Lead transfer of new processes and technologies to-and from clinical manufacturing while ensuring operational excellence and cGMP compliance.
Closely collaborate with process development and (clinical) manufacturing to ensure seamless technology transfers.
Roll out of raw materials and single-use equipment: risk assessments, specification setting and design of single use assemblies.
Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
Design/generation of DS manufacturing recipes in distributed control system.
Trending and analysis of manufacturing data and generation of campaign reports.
Support establishment of appropriate data management systems for knowledge management.
Support of regulatory filings and application of Quality-by Design (QbD) principles.
Lead continuous digitalization of the clinical manufacturing plant.
Drive continuous process optimization, implementation of new technologies and operational improvements in close collaboration with process development.
Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department.
I nterested? For this position you’ll need the following education, experience and skills:
Master’s Degree preferably in Bioengineering or related fields.
At least 3 years of industrial experience, preferably in a GMP environment (chemical, pharmaceutical or biotech).
Expert knowledge of Biologics Manufacturing, specifically of Drug Substance Manufacturing (Upstream-and/or Downstream). rAAV Manufacturing and/or Process Development experience would be highly beneficial.
Excellent Process Engineering skills including scale-up and knowledge of tech transfer principles.
Experience with sterility concepts, bioburden reduction approaches, including systematic risk assessments and troubleshooting.
Hands-on experience with mammalian cell culture- and/or purification systems.
Experience with distributed control system (e.g. PCS7, Delta V,…)
Very good command in English, a good command in French is a strong asset.
Track-record of delivering project milestones within tight timelines.
Ability to prioritize project work and make effective use of available resource.
Strong interpersonal skills to communicate and maintain good working relationship with internal and external stakeholders.
Strong problem-solving skills for process issues related to manufacturing process or to facility design.