Upstream Process Manager

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To strengthen our Biotech Clinical Manufacturing Sciences (BCMS) team in Braine-l’Alleud (Belgium), we are looking for a talented individual to fill the position of: Upstream Process Manager.

As an Upstream Process Manager, you will support the manufacturing activities on-going in the Biologicals Pilot Plant through:

• Organize and routinely manage the Upstream suites of the Biologics Pilot Plant to ensure the efficient implementation and execution of manufacturing processes under cGMP at the pilot scale (400 liters and 2000 liters).
• Perform cGMP manufacturing of drug substance (DS) for clinical trials (Phases I, II and III) from Cell Banking (MCB, WCB) through sterile filtration of the Cell-Free Cell Culture Fluid (CCF) into the harvest Hold Tank.

More specifically, you will contribute by:

• Managing the Upstream Production team (up-to 5 direct reports) including, identification of resource requirements, ensuring all team members are trained and competent to execute their role, professional development of team members.
• Being responsible with the team to coordinate and resolve Quality Notifications.
• Ensuring all MBRs, log-books, forms are completed by USP team members on a daily basis to the principles of ALCOA+ and any deviations are raised on-time according to SOP.
• Ensuring robust planning and timely execution of manufacturing activities.
• Pursuing continuous improvement concepts and aim highest efficiency minimizing cycle times and number of staff required to operate the plant.
• Ensuring cGMP compliance of manufacturing operations and batch creation/documentation, as well as effective CAPAs and process-related changes implementation.
• Writing, reviewing and approving documentation including SOPs, MBRs and risk assessments.
• Striving for operational excellence and achieving high success rates by preventing/minimizing bioburden issues and product losses during USP and major deviations leading to OOS results.
• Supporting project implementation within Bio Pilot Plant/Upstream suites following BCMS rules according to Cost/Timing/Quality (CAPEX Projects).
• Driving effective process monitoring, data management and process learning and highlight potential process improvements.
• Participating in the transfer of processes from small scale development units to the pilot plant and from pilot plant to commercial manufacturing sites (internal/external). Writing, reviewing and approving documentation required for technology transfer and working as part of a matrix team for delivering the technology transfer on time.
• Working closely with and providing input to small scale development groups with regard to platform improvements and ensuring the scalability and manufacturability of production processes.
• Building and maintaining effective relationships with internal customers and external contacts.
• Participating in the design of new – or modified process equipment, staffing, (re-) qualification of equipment, (re-) validation and regulatory inspections of the UCB Biologics Pilot Plant at the Braine L’Alleud Site.

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

• Bio Engineer Master’s Degree required.
• At least 5 years’ experience of cell culture-based production, optimization, scale-up and technology transfer, preferably at pilot scale or higher (>300 liters).
• Experience/Track Record with large scale cGMP USP bio processing, particularly involving sterility concepts, bioburden reduction approaches, yield improvements, including systematic troubleshooting.
• Excellent command of pilot-scale technologies and unit operations involved in upstream bio processing (cell culture, bioreactors, media preparation, continuous centrifugation, filtration etc)
• In-depth understanding of Regulatory and Quality requirements for clinical cGMP production of biological products under clinical development.
• Experience of interaction with CMOs and CROs.
• Excellent people leadership and motivation skills.
• Interpersonal skills to communicate and maintain good working relationships with internal customers (QA, QC, Regulatory Affairs, Commercial Manufacturing, Process Development Groups) and external customers (CMO and CRO).

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.