Mass Spectrometrist, specialized in quantitative proteomics

仕事内容

Make your mark for patients

To strengthen our Biotech Sciences team, we are looking for a talented individual to fill the position of Mass Spectrometrist, specialized in quantitative proteomics,based in Braine, Belgium.

The removal of residual Host Cell Proteins (HCP) from the drug substance to an acceptable level is one of the goals of the biotherapeutics manufacturing process. HCP are more or less the proteome of the production cell and they are co-produced with the active molecule during cultivation of the cells in the bioreactor. These impurities might cause immunogenicity in certain patients, some may as well as act as enzymes and thus may negatively influence the stability of the drug product. HCP therefore need to be quantified and, if possible, characterized. The gold standard for the quantification of HCP in a regulated, GMP environment, is ELISA (enzyme-linked immunosorbent assays). However, it quantifies the sum of HCP without information on the individual proteins. Recently, mass spectrometry (MS) techniques have helped identify the separate HCP (quantification is still challenging).

At UCB, more precisely in Biotech Sciences (BTS), MS on HCP support process development and investigations. UCB is further pioneering the implementation of MS for identification and quantification, in a GMP environment this time, as a potential replacement to ELISA methods for batch release and for clearance studies. The challenges of quantifying HCP by MS are multiple as we are speaking of up to thousands of different proteins present at trace levels together with the active ingredient, a protein itself. Intense networking with our peers and regulators is necessary to check the soundness of our strategy, as we are one of the first laboratories in the industry to explore this exciting path.

The primary goal of the function is to provide scientific expertise to contribute to analytical development activities, in first instance on MS methods for the quantification of host cell proteins, but also to other quantitative applications of MS for proteins. The function is in the Analytical Development Sciences for Biologicals (ADSB) department, more precisely in the Physico-Chemical Method Development (PCMD) group. The responsibilities span from early clinical phases projects to commercial products. The team has to develop robust and efficient methods, validate those methods to the required regulatory requirement standards and transfer them to internal (IPC-BPP, CSS or QC) or external partners (CMO/CRO). The group also provides analytical support and expertise to process understanding and process validation of UCB biological processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners. All activities are delivered to appropriate agreed quality standards and timelines and in accordance with group and departmental objectives.

You Will Contribute By

• Develop and validate under GMP (good manufacturing practices):
• DDA and/or DIA methods for the quantification of HCP (host cell proteins) in drug substance or in-process samples
• Multi-attribute methods and other MS methods applied to proteins
• Design experiments
• Autonomously manage, supervise and perform daily laboratory activities related to method development, validation, transfers, upport to process, investigations
• Prepare and review/approve documentation (procedures, protocols, reports)
• Analyse results
• Verify data
• Present/discuss results in project team meetings
• Provide analytical expertise to projects
• Represent ADSB in cross functional project teams
• Interact with regulatory teams for file preparation and submission
• Liaise with other departments (e.g. QC, research) or external partners to ensure analytical knowledge transfer

All these activities will be performed in respect of the material and premises, to HSE rules and in compliance with the GMP rules and with the regulatory requirements for each development phase of the product

Interested? For this position you’ll need the following education, experience and skills:

• A PhD level is preferred, with proven experience on MS applied to the quantification of complex mixtures of proteins applying, eg, the DIA or DDA approaches. Another education level with experience is of course equivalent to a PhD.
• Previous experience in the pharma industry or in a regulated environment is a plus but not a must.
• The candidate will show objective oriented skills, ie, an ability to deliver robust and documented methods within agreed and realistic timelines.
• Communication skills to explain your work to non-specialists will be appreciated.
• The ability to communicate in (professional) English is a must, French is a big plus.

Applications should include a CV and cover letter describing your motivation and experience, as well as the name of two referees and the date from which you would be available.

For additional questions regarding the position you can contact Cyrille Chéry.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for 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 equitable 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.

Learn moreabout sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.