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

Head of Group Biossay

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  67136

Help us transform patients' lives.

 

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

To strengthen our Analytical Team, based in our Analytical Development Sciences for Biologicals department in Braine, Belgium we are looking for a talented individual to fill the position of: Head of Bioassay Development.

As a Head of Bioassay Development, you will identify and foster purposeful partnerships with key scientific influencers to drive new sources of patient value.

 

You like to work in an environment where you can:

 

  • Be a support to Preclinical Development, Clinical Development Phases I, II and III, QC by developing reliable bioassay methods that are representative to the drug mechanism of action
  • Manage the delivery of analytical methodologies, validation, stability studies, release of DS and DP and tech transfer of methods to QC and/or from/to CMOs/CROs according to business needs (e.g. quality and timelines)
  • Ensure the provision of analytical troubleshooting expertise to internal/external (e.g. CMO/CRO) business partners (e.g. RA, QA, QC, IP)
  • Actively contribute to regulatory submissions with internal/external (e.g. CMOs/CROs) business partners (e.g. RA, QA, QC, …).
  • Foster state-of-the-art bioassay analytical skill set to meet and exceed industry standards with respect to science, quality standards and regulatory guidance
  • Support the business mission of UCB becoming a Biopharma Leader by innovating, implementing and, when appropriate, publishing innovative analytical methodologies

This function will support the New Biological Entities manufacturing processes and products with the aim of providing treatment to unmet medical needs through antibody-based drugs.

The Head of Bioassay Development has the responsibility to manage all NBE bioassay development activities (including cell-based and biochemical binding assays) for NBE Development projects in Braine throughout clinical phases (from phase 1 readiness to launch) and the lifecycle of the product.

All activities will have to be delivered to appropriate agreed quality standards and timelines and in accordance with departmental mission statements.

You will contribute by:

 

  • Ensuring proper management of internals (11 scientists) and contractors
  • Providing analytical support to any UCB product and process development to ensure the success of business-critical projects;
    • Ensure development and validation of reliable and efficient bioassay methods from early phase to commercialization (including product lifecycle) that complies with release and stability testing phase-based requirements
    • Liaise with Research and QC's or external partners to ensure analytical knowledge transfer
    • Provide analytical support to Process development departments (incl In-Process Controls Checks as appropriate)
    • Validate and approve analytical results as appropriate
    • Contribute to all technical documents in line with authorities requirements
    • Interact with regulatory agencies to drive successful applications
    • Support regulatory submissions by presenting the results of analytical assays, as requested by the business, to Health Authorities
    • Contribute to development and implementation of an NBE analytical strategy
  • Working hand in hand with the Quality Division to ensure compliance with all appropriate regulations and SOPs and with Biosafety/HSE to ensure application of all necessary security regulations
  • Contributing to the systems management of environment and maintain ISO 140001 certification
  • Influencing and networking beyond own team including externally (e.g. regulator through industry consortiums). Representing UCB in external working groups and in international conferences, as appropriate.

 

 

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

 

  • Ph.D. in Molecular/cell Biology or equivalent
  • ≥ 8 years of relevant analytical development experience in a pharmaceutical company
  • Experience in relevant bioassay analytical techniques related to Biological molecules characterization
  • Must have experience in a GMP regulated laboratory
  • Extensive knowledge of scientific principles relevant to bioassay analysis on NBEs such as cell-based and biochemical binding assays
  • Experience with preparation of development reports and standard operating procedures
  • Experience with statistical approaches for assay development/validation and data analysis for biological assays (i.e. USP1032/1033/1034; EP5.3)
  • Familiarity with lab instrument automation is a plus
  • Project management skills:
    • Excellent interpersonal, verbal, and written communication skills.
    • Must have good managerial, organization, leadership and analytical skills, ability to handle multiple priorities.
  • Problem solving skills: able to direct the activities of analytical technicians to solve problems pertaining to development activities.

 

 

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. 

Apply now »