Gene Therapy Qc Testing

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 QC Testing (Associate) Scientist who is
rigorous, autonomous and team oriented to join us in our
Analytical Development team, based in
Braine-l'Alleud,
Belgium

About the role


This role will support the development of recombinant Adeno-Associated Virus (rAAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through gene therapy.

The two main objectives of the GT QC Testing (Associate) Scientist are:

  • To implement high throughput analytical tools supporting the process development, release and stability of multiple therapeutic gene therapy programs throughout clinical phases (from phase 1 to readiness to launch).
  • To support the development, validation, tech transfer (to internal or external partners) and execute fast and reliable assays to support the clinical development of AAVbased Gene Therapy Products in accordance with current rules and procedures (_e._ GMP/GSP).


All these activities will be performed in respect of the material and premises, in compliance with the HSE/Biosafety/GSP or GMP rules and with the regulatory requirements for each development phase of the product.


Who you'll work with

:

-
Grégory Parvizi as your Manager and many others talented colleagues at transversal level.

What you'll do

:

  • Contribute to analytical and process development, drive results.
  • Support release and stability testing of Gene Therapy Products by validating, coordinating, executing and/or tech transferring fast, reliable and QC friendly assays.
    The position consists of a significant time spent at the bench (~80%).
:

  • Crosstrain and provide support for upstream/downstream process sciences, characterization and vector biology teams.
  • Provide high quality documentation (procedures, protocols, reports) of all technical work performed in the lab in accordance with data integrity requirements.
  • Verify data (double check, data check).
  • Participate to the result analysis and trending.
  • Present/discuss results in team meetings.
  • Prepare written procedures and instructions.
  • Sustain scientifically current (state of the art) laboratory environment and/or data systems.
  • Work independently and cross functionally across various UCB teams related to analytical and process sciences activities.
  • Manage priorities and engage/communicate in a multidisciplinary environment. Support the development of the UCB GT strategy internally as well as externally (_e._ CMOs/CROs).

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

  • Master's degree preferred. Bachelor's degree with sufficient experience could be considered.
  • Indepth understanding of analytical methods within the biopharmaceutical industry (_e._ viral vector quality control experience in industrial research or contract manufacturing setting).
  • A previous experience in a regulated laboratory environment (_g._ GLP/GMP).
-
Hands-on experience in developing analytical methods in a QC environment

:

  • Molecular Biology: ELISA, PCR (qPCR and ideally dPCR), Western Blots, Gel Electrophoresis,

AND/OR

  • Biophysics: HPLC, UHPLC, dynamic and static light scattering,
  • Previous development or validation of methods for viral vector products is a plus.
  • Deep understanding of characteristics to be considered for analytical method validation.
  • Knowledge of statistical tools supporting the development/characterization of reliable analytical methods.
  • Knowledge and understanding of regulatory requirements and of HSE/Biosafety/GMP-GLPGSP rules.
  • Good knowledge of English and ability to read, analyze, and interpret common scientific papers.
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/nation

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