Date: Feb 10, 2019
Location: Braine L'alleud, Walloon Brabant, BE
We are looking for a
Senior Scientist in Upstream Process Sciences
Nature and scope of the position
The Upstream Process Senior Scientist will support late stage process optimization, characterization, transfer and clinical/commercial manufacturing for cell culture processes producing protein therapeutics.
The successful candidate will also help defining and implementing the strategic directions of the Upstream Process Sciences group, with a specific focus on late stage development activities. She/he will help driving the definition of the upstream process control strategy, support process validation and ensure comparability for biologics introduction at UCB and external industrial sites.
Providing technical assistance to clinical and commercial manufacturing at UCB and external sites including change assessment, process monitoring, troubleshooting and continuous improvement will also be part of this role.
The Senior Scientist will:
* Apply his/her strong technical expertise and professional practices to contribute to Upstream Process Sciences' mission, by helping to define and implement the technology innovation roadmap. This will be done with strong linkage to early stage process sciences, clinical and commercial manufacturing.
* Lead late stage process development activities such as risk assessments, process characterization, preparation of process performance qualification/validation activities at UCB or contract manufacturing organizations. In addition prepare and/or review relevant CMC sections of the biologics license application.
* Contribute or lead the design, improvements and deployment of best practices together with other Process Sciences Departments and other functional partners by incorporating a deep understanding of regulatory requirements and manufacturability.
* Provide input in to definition of technical strategy for next generation process development platform projects and/or external collaboration projects.
* Actively participate to industry and academic consortia, forums and conferences to understand future industry predictions and opportunities to develop review and refine innovation strategy. Help shape its evolution by representing UCB in external forums.
* Participate in major troubleshooting for complex deviations (non-conformance) in manufacturing and propose corrective actions when appropriate.
* Write/prepare and or review all the upstream process sciences technical reports that support the regulatory CMC dossier in preparation for the Biological License Application and prepare responses to follow-up questions from regulatory agencies around the world.
* Liaise and promote the technical and scientific exchange with other process development groups and partner departments.
* Apply UCB's health safety and environment policies and rigorous standards. Participate in continuous improvements of HSE by conformance checks on laboratory set-up, construction and organization as well as day-to-day standards and procedures in close collaboration with the HSE department.
Experience and skills
* Education: Master Degree or PhD in biochemistry, molecular/cell biology or bioengineering with 3-5 years' experience in process development/manufacturing sciences
* Very good English skills, written and spoken, good level of French is a major asset
* Demonstrated skill in mammalian/microbial fermentation cell culture and aseptic techniques
* Experienced in the operation and analysis of various bioreactor/fermenter systems (rocking mode, stirred glass, stirred stainless steel) at various scales
* Strong laboratory skills and a track record of spending >50% of current and past work function in the laboratory
* Experience with cGMP and large-scale manufacturing equipment and practices and/or experience with technology transfer to cGMP facilities would be beneficial
* Experience in process intensification, high throughput technologies for cell culture, statistics, bio-analytics, media development and/or digitalization would be beneficial
* Ability to learn and use appropriate data management concepts and tools
* Ability to author and approve comprehensive and accurate SOPs and protocols/reports
* Ability to work matrix and virtual team across geographies and time-zones
* Ability to maintain good working relationships with internal customers/partners
* Experience in effectively managing placement students and/or associate scientists is required, as is effective communication, oral and written, in a multi-disciplinary, project-driven work environment would be beneficial
* Ability to structure, process and communicate large amounts of data
* Flexible and able to produce results under tight deadlines
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