Gene Therapy Drug Product Scientist

il y a 1 semaine

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

Make your mark for patients


We are looking for a
Gene Therapy Drug Product Scientist who is a hands-on team player with a keen interest for innovation and a can-do attitude to join us in our
Gene Therapy Process & Analytical Sciences team, based in
Belgium (Braine-l'Alleud and Leuven sites).


About the role


You will be responsible for supporting Drug Product Process Development activities for UCB's recombinant adeno-associated virus (rAAV) gene therapy products.

You will be accountable for design and management of process development, characterization and technology transfer of rAAV drug product processes.


You will also collaborate with internal and contract laboratories to support development of drug product processes and definition of an AAV production platform for UCB's gene therapy offerings.


Who you'll work with:


You will report to Pankaj Shende and collaborate with team members of Process Scientists and Engineers supporting the establishment and operation of a development and manufacturing facility for gene therapy products.


What you'll do:

  • Design, approve, review and execute studies for the development of drug product processes supporting First in Human studies through to commercialization for rAAV gene therapy products.
  • Author & review technical documents including CMC regulatory sections, process descriptions, study designs, SOPs, technical position papers, & technical reports.
  • Identify, evaluate, and implement new technologies to improve and refine rAAV drug product platforms.
  • Provide scientific leadership for the Drug Product Process team internally, crossfunctionally (e.g. primary packaging, devices, formulation, drug substance, etc.), and to partners and contract organizations (eg. CDMOs).
  • Participate to the establishment of a smallscale drug product process model.
  • Support rAAV development and manufacturing facility design.

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

  • PhD (in Chemical Engineering, Bioengineering, Biology, Biochemistry, Virology, or related fields) with industry experience, 3 years of experience (Master), or 5 years of experience (Bachelor) in drug product process development of large molecule, viral vectors, vaccines, or cellular therapies.
  • Excellent technical knowledge of biologics drug product manufacturing, aseptic processing, drug product commercialisation, primary pack selection, parenteral product development, process development and scaleup. Experience with AAV manufacturing is highly desired.
  • Knowledge of cGMP manufacturing guidances and experience with technical investigations, problem solving and root cause analysis.
  • Proven experience of working on innovation projects and/or areas where regulations/guidance is still being developed.
  • Good understanding of the issues and challenges of taking products from research to development and on into commercialisation.
  • Very good command in French and English, both spoken and written.
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 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.

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