Upstream Group Leader (Late Stage)

工作内容

Make your mark for patientsWe are looking for an Upstream Group Leader (Late Stage) to join us in our Biologics DS Process Sciences department, based in Braine-l’Alleud, BelgiumAbout The RoleThe Upstream (USP) Group Leader (Late Stage) will be responsible for providing support for CMC Process Development activities of antibody-based therapeutics including technology transfer activities enabling drug manufacture.Please note that we are looking for someone that is going to endorse this role at Principal Scientist level.Who You’ll Work With

• Wolfgang Paul (Head of Mid & Late-Stage Process Sciences) as your Manager.
• Your team members composed of 6 Scientists.
• A lot of internal customers (QA, QC, Regulatory Affairs,…) and external partners (CRO’s).

What You’ll Do

• Timely and in budget Upstream Process Development across projects.
• Effective recruitment and training concepts for all late-stage process science staff.
• Strive for operational excellence and achieve high success rates for upstream process development, scale down/scale up, technology transfer and Industrialization.
• Drive effective process monitoring, data management and process learning and highlight potential process improvements.
• Efficient characterization of processes.
• Efficient process development of NBE’s.
• Support to UCB’s standard process platforms.
• Participate in the transfer of processes from small scale development units to the pilot plant, MSAT and to commercial manufacturing sites.
• Work closely with the Biologics Pilot Plant and the technology transfer group with regard to platform improvements and ensuring the scalability and manufacturability of production processes.
• Utilize process and laboratory derived data to support technical investigations and aide in process optimization/development.
• Provide an upstream process expert and key point of contact for each assigned externally developed process. Provide guidance and feedback to team members to ensure successful collection and analysis of all existing data and reports relating to assigned projects. Help them perform gap analysis in collaboration with the technology transfer management team. Plan process understanding and characterization activities with a clearly defined scope, required resources and timelines. Effectively communicate those plans to all of those concerned (TST, Management, Downstream Process Development teams, Analytics group etc).
• Supervise and perform daily laboratory activities relating to media making, support cell banking, inoculum and fermentation/cell culture process development and characterization as well as in process analytical methods. Provide technical expertise in matters regarding cell culture process development.
• Author and/or review relevant CMC sections for regulatory filings.
• Author and/or review technical reports, process summaries, protocols, and quantitative analyses. Perform fundamental literature and patent searches related to processes under development.
• Build and maintain effective working relationships with internal customers and external contacts.
• Build and maintain a strong external academic network, peer recognition of highest scientific and technical excellence and strong relationship with regulatory agencies regarding CMC matters.
• Define UCB’s Biologics control strategies for upstream processes.
• Understand the impact of upstream processes on downstream processes and manufacturing facilities.
• Ensure successful validation of processes with a strong understanding of global regulatory requirements.
• 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.

Interested? For this role we’re looking for the followingeducation, experienceandskills

• PhD or master’s degree.
• At least 8 to 10 years of experience within the industry with upstream bioprocessing, particularly late-stage process characterisation and validation, including systematic troubleshooting.

Please note that we are looking for someone that is going to endorse this role at Principal Scientist level.

• Proven track record of drug substance commercialization and manufacturing science & technology, technology transfer expertise for monoclonal antibodies.
• Working knowledge of D ownstream & A nalytics .
• Proven Management and Leadership experience/skills.
• Very good command in English, good command in French is a strong asset.

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 UsUCB 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 more about 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.