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Let's push the boundaries together and make the most of your talents!

Analytical Quality Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  72086

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

 

To strengthen our Global Quality organization, based in our hub in Bulle, Switzerland or in Braine l’Alleud, Belgium, we are looking for a talented individual to fill the position of: Analytical Quality Lead.

 

As an Analytical Quality Lead you will support operational Quality Assurance activities for a monoclonal antibody related to the analytical testing for product and process development, process validation and preparation of the marketing authorization submission.

 

You like to work in an environment where you can:

 

  • Be part of an ambitious organization with promising biopharma products pipeline.
  • Help to improve the lives of people with this severe, chronic disease.
  • Work partnering with QA at UCB and vendor sites, and collaboration with UCB development and commercial analytical teams Regulatory Affairs and other UCB teams.

 

You will contribute by:

 

  • Supporting Change control management and Product Change Control Committee.
  • Managing deviations.
  • Reviewing and approving analytical documentation related to:
    1. manufacture and analytical testing (analytical methods, specifications).
    2. analytical studies as part of Process Validation.
    3. methods transfer studies / validation studies / stability studies.
    4. characterization studies (by analytical techniques such as Electrospray Ionisation Mass Spectrometry, Circular Dichroism, Intrinsic Fluorescence, FTIR, etc.).
  • Reviewing and approving analytical Regulatory CMC submission sections.
  • Working closely with development and commercial analytical teams and Regulatory Affairs teams to ensure that all QA services for the project are provided in an effective and efficient way.

 

Interested? For this position you’ll need the following education, experience and skills:

 

  • Master’s degree in life science.
  • Min 5 years of professional experience & knowledge in the pharmaceutical industry in the GMP operations environment, using analytical techniques for protein routine testing (HPLC, SDS-Page…) and protein characterization (ex : Electrospray Ionisation Mass Spectrometry, Circular Dichroism, Intrinsic Fluorescence, FTIR…) and min 1 year of experience in a related Quality role.
  • Hands-on field experience in failure investigations, root cause analysis, deviation review.
  • Solid knowledge about:
    1. Good Manufacturing Practices (Eudralex Vol. 4) and 21CFR part 210 & 211.
    1. Q8 (R2) Pharmaceutical development, Quality By design.
    1. Substance and Drug Product manufacture for biological products (ex: monoclonal antibodies, sterile forms) and GMP process validation.
  • Excellent communication skills and able to work in a multi-cultural environment.
  • Ability to work autonomous and to independently analyse data and information to draw conclusions and make effective decisions.
  • Fluent and confident use of English language verbally and in reading & writing.

 

Why you should apply

 

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.


 

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 


Job Segment: Quality Manager, Neurology, Analytics, Immunology, Quality, Management, Healthcare

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