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Senior Scientist (Piloting & Scale-Up for Biologics)

  • UCB - Union Chimique Belge
Braine-l'Alleud, Belgium
Full-time
Published:
  • UCB - Union Chimique Belge
Braine-l'Alleud, Belgium
Full-time
Published:

ABOUT THE ROLE:

Our Senior Scientist will lead and deliver a part of the Piloting & Scale-up team priorities which primarily focus on the development of pilot scale processes for the production of drug substance (DS) for toxicological studies and the successful development, scale-up and technology transfer of DS processes across all stages of clinical development, including supporting GMP troubleshooting activities and derisking the scale-up of future processes.

WHO YOU WILL WORK WITH:

  • Richard Davies, your Manager;

  • Your team of Scientists and contractors/interns, ensuring delivery to team objectives and project milestones and supporting the growth of those individuals. Fostering an environment for direct reports to learn, develop and grow through definition and progression of objectives and personal development plans;

  • The wider DS process development team, including the understanding and supporting of Downstream Processing requirements as appropriate;
    Colleagues in GMP facilities to ensure the successful development and scale-up of our Upstream and harvest processes;

  • All the above, in a matrix and virtual environment across geographies and time-zones.


WHAT YOU WILL DO:

  • Operating pilot scale upstream process activities undertaken in the Biologics Process Sciences laboratories. Including the design of experiments, lab coordination, scheduling, resourcing and training of staff, sourcing of raw materials, equipment maintenance as appropriate;

  • Operating harvest process activities at lab and pilot scale and supporting the future strategy for successful harvest processing of UCB NBE’s;

  • Providing technical expertise in upstream and harvest processing to Project Teams and Senior Management as appropriate, supporting technical and scientific exchange across the organization;

  • Supporting the understanding and application of fundamental scaling principles and rationale to derisk scale-up and clinical/commercial readiness at UCB;

  • Driving innovation to offer cutting-edge manufacturing process options. Defining the biopharmaceutical processes of the future, potentially leading to patent inventions;

  • Ensuring traceable records of lab work, experimental design and report writing in good scientific English (e.g. batch records, lab notebooks, protocols, reports);

  • Applying UCB’s health safety and environment policies and rigorous standards. Participating in continuous improvements of HSE culture.


FOR THIS ROLE WE ARE LOOKING FOR THE FOLLOWING EDUCATION, EXPERIENCE AND SKILLS:

  • Master or PhD degree in a related field;

  • Demonstrated expertise in the operation of lab and pilot scale cell culture processes, including the use of various bioreactor systems, relevant operating control software and excellent aseptic techniques;

  • Expertise and knowledge in harvest processing of Biologics is preferred;

  • Knowledge of CMC Process Development and regulatory requirements through pre-clinical, clinical and commercialization phases is preferred;

  • Knowledge in Downstream Processing is preferred;

  • Experience in People Management with the ability to coach and mentor team members;

  • Ability to learn and use appropriate Data Management concepts and tools;

  • Ability to author comprehensive and accurate SOPs and protocols/reports;

  • Ability to prioritise own experimental work and understand how these fits with the wider priorities and ongoing projects, making effective use of available resource;

  • Ability to troubleshoot technical issues using rational thought processes based on process and equipment knowledge and understanding and reacting to such issues in a calm, controlled manner to provide or contribute to a solution;

  • Ability to communicate effectivelyand connect with peers from different functions (matrix organization) to ensure projects are delivered;

  • Excellent written and spoken English, additionally good command in French is preferred.

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