Gene Therapy Downstream Process Sciences Senior Scientist
Gene Therapy Downstream Process Sciences Senior Scientist
UCB - Union Chimique Belge
Braine l'Alleud, Belgium
We are looking for a Gene Therapy Downstream Process Sciences Senior Scientist who’s dynamic, resilient and flexible to join us in our Gene Therapy Process Development team, in Belgium.
About the role
The Gene Therapy (GT) Downstream Process Sciences Senior Scientist will be responsible for supporting Downstream Process Development activities for UCB’s recombinant adeno-associated virus (rAAV) gene therapy products. This individual will be acting as a downstream project lead, accountable for design and management of process development, characterization, and tech transfer of rAAV purification processes.
The Senior Scientist will collaborate with internal and external laboratories to support development of downstream processes and definition of an AAV production platforms and manufacturing facility requirements for UCB’s gene therapy offerings.
This role will start at a temporary site based in Leuven to support laboratory activities and will travel periodically to UCB site based in Braine-l’Alleud for department meetings. This individual will function remotely during the design and build of the new gene therapy laboratories then will move onsite to support start-up and operation of the development labs when the facility is online at Braine l’Alleud. The candidate may also travel (10%) to directly support operations at other sites.
What you’ll do:
- Act as a downstream process development technical subject matter expert and downstream project lead for rAAV gene therapy products leading the downstream CMC development, supporting facility design, Quality-by-Design (QbD) and pre-clinical and clinical manufacturing;
- Collaborate extensively with cross-functional teams like Upstream, Analytics, Regulatory and Quality and present to cross-functional internal and external CMC technical teams;
- Design downstream project work packages in accordance with project timelines and execution of chromatography and filtration for development of processes supporting First in Human studies through commercialization for rAAV gene therapy products;
- Support and implement digitization initiatives like ELN and automation and contribute actively in Downstream support functions like inventory management, lab organization, equipment maintenance, vendor managment;
- Author & review technical documents including CMC regulatory sections, process descriptions, study designs, SOPs, technical position papers, & technical reports;
- Strictly adhering to EHS and Compliance guidelines and actively contribute to refine the compliance structure and EHS practices;
- Guiding new joiners to familiarize them with lab workflow and handling of equipment;
- Identify, evaluate, and implement new technologies to improve and refine rAAV purification platforms.
Interested?
For this role we’re looking for the following education, experience and skills:
- PhD or master’s degree in chemical engineering, bio engineering, biochemistry, or related disciplines;
- Minimum 6 to 8 years of industrial experience in CMC Process Development of large molecules or cellular therapies;
- Excellent technical knowledge of biologics downstream sciences, scale up and process development (chromatography, TFF, NFF). Experience with rAAV early stage and late stage process development is desired;
- Proficiency in handling, troubleshooting and automation of chromatography skid (AKTA), TFF skid and other relavant equipment;
- Knowledge of cGMP manufacturing guidance and experience with technical investigations and root cause analysis;
- Excellent communication, presentation skills and management of relevant stakeholders;
- Experience in Technical Project management;
- Experience with data and statistical analysis;
- Very good command in English, both spoken and written.
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