Talent.com
Deze vacature is niet beschikbaar in je land.
Analytical Method Performance Expert

Analytical Method Performance Expert

UCBBraine L'alleud, Walloon Brabant, Belgium
27 dagen geleden
Functieomschrijving

Make your mark for patients

We are looking for an Analytical Method Performance Expert who is analytical, collaborative, and detail-oriented to join our team Manufacturing Science and Technology (MSAT), based at our UCB campus located in Brussels, Belgium.

About the role

You will focus on analytical method performance for commercial products. You will need a strong understanding of analytical method lifecycle management.

Who you will work with

You will work closely with the Industrial Analytical Program team, the Analytical Development Science team, and the Patient Supply QC teams.

What you will do

  • You will perform periodic Invalid Trend analyses by collecting and evaluating data from UCB validated systems.
  • You will be responsible for evaluating the Invalid Rates for UCB Analytical Methods.
  • You will manage recurrence and root cause analyses to detect trend alerts.
  • You will define and lead investigation teams to address method issues and remediation plans.
  • You will report the Trend Analyses outcome in UCB documentation systems.
  • You will provide transversal analytical expertise on methods and specs, including implementation & changes of methods, troubleshooting.

Interested?

For this role, we are looking for the following education, experience, and skills :

  • Bachelor's or Master's Degree in a relevant field.
  • Analytical expert with 3+ years of experience in pharmaceutical analysis, preferably monoclonal antibodies.
  • Proven project leadership skills including planning, monitoring, issue resolution, decision making, and reporting.
  • Strong understanding of all analytical disciplines related to CMC for late-stage development and commercial products.
  • Expertise in Regulatory Affairs and Quality applied to analytics is a plus.
  • Experience in GMP is a must.
  • Fluent in English (mandatory) and French (preferred).
  • Key technical background : chromatography (HPLC / UPLC); capillary electrophoresis, detection techniques (UV / Vis, MS), ELISA, USP, EP, and JP tests. Large molecule experience is preferred.

    • 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!

    Maak een vacature-alert aan voor deze zoekopdracht

    Expert • Braine L'alleud, Walloon Brabant, Belgium