Upstream Group Leader

il y a 1 semaine

Brainel'Alleud, Wallonie, Belgique UCB S.A. Temps plein

Make your mark for patients
We are looking for an
Upstream Group Leader (Late Stage) to join us in our
Biologics DS Process Sciences department, based in
Braine-l'Alleud,
Belgium

About the role


The 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 latestage 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.

Interested? For this role we're looking for the following
education, experience
and
skills

  • PhD or master's degree.
  • At least 8 to 10 years of experience within the industry with upstream bioprocessing, particularly latestage 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 Downstream & Analytics.
  • 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 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, respec

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