Downstream Biomanufacturing Sciences Specialist

Job description

Make your mark for patients To strengthen our Clinical Manufacturing department, we are looking for a talented and motivated individual to fill the position of: Downstream Biomanufacturing Sciences Specialist , based in Braine-L’Alleud , Belgium . About the role : You will ensure that the manufacturing area is operating at peak efficiency and that product delivery complies with HSE (Health, Safety, Environment), GMP (Good Manufacturing Practice), and technical requirements by optimizing daily activities and performance across the department. You will actively and autonomously support the preparation, execution, review, and release of the clinical campaigns manufactured (technical & GMP batches phases, I, II, and III, as well as cell bank). W ho you’ll work with : You will be assigned to the Bio Drug Substance Operations team, and you will engage in cross-functional interactions with other Process Specialists as well as with others. What you’ll do : Support the process transfer from lab to pilot scale of the new products or campaigns. Create documentation for regular process and process improvement: master batch record, check-list, coaching sheet and additional instructions. Elaborate mid-term production planning and activities in close collaboration with the Manager. Perform routine (on-the-floor) support and spot-check during manufacturing campaigns. Assist and ensure that operational goals are met on a timely basis. Provide coaching/trainings and provide GMP & scientific support to team members. Check and interpret raw data generated and compiled the data sheet during the campaign and define or support action plan and corrections if needed. Understand the process and the need, collect feedback from Subject Matter Experts and in case of technical issue or discrepancies, suggest solutions to be able to meet the qualities requirements and the planning. Effective deviation and change control management as well as in the action plan follow-up (CAPA and action item) with respect of timelines. Act as Project Lead in Downstream field from implementation, monitoring and documentation point of view. Support tech transfer and process performance qualification activities by contributing, as Manufacturing Specialist, to process fit-gap assessments, supportive troubleshooting studies, process scale-up to internal manufacturing and CMO’s. Support regulatory inspections and submissions by the participation and representation of production unit during audits. Downstream representative in global & cross-functional project teams by building relationships throughout and across departments to facilitate the sharing and gathering of information. Back-up to the team members. Interested ? For this role we’re looking for the following education, experience and skills : Degree in a relevant scientific or engineering discipline. Experience with pilot or large-scale pharmaceutical manufacturing, in a GMP environment. Strong knowledge in Downstream. Knowledge in equipment qualification & cleaning/process validation. Must be able to work on multiple simultaneous tasks with limited supervision. Fluent in French and technical English. Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Requisition ID: 94003 Recruiter: Mégane Libert Hiring Manager: Jessica Rood Talent Partner: Caroline Lonchay Job Level: SA III Please consult HRAnswers for more information on job levels.