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QbD / PAT Scientist - Belgium  

UCB (company)


Posted on : 13 May 2017

Project Description

  • With more than 8500 people in approximately 40 countries, our company  offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  
  • Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at our company.
Job Scope and responsibilities 
  • The successful candidate for this job will become a key member of the Drug Product NCE development department. 
  • The primary responsibility of this position is to apply  in a systematic manner QbD (risk assessment, PAT, DoE and modelling) to support formulation and process development of NCEs. 

In this context the main responsibilities include:   
  • To act as the point of contact for QbD and PAT in DP formulation and process development. 
  • In support of formulation and process development of the product portfolio, to select and perform relevant PAT studies, design relevant DoEs and conduct statistical data analysis. 
  •   To identify and understand the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles as well as properties of materials.   
  •   To evaluate critical to scale parameters and equipment parameters that can affect product performance at larger scale. 
  • Effectively use PAT and scale up principles of unit operations to confirm or modify understanding of CPPs at pilot and manufacturing scale.   
  •   To define and evaluate CQAs, CPPs and CMAs and determine as an outcome of the risk assessment  the control strategy including relevant models, PAT systems and process regulations.   
  •   Using PAT & chemometric modelling, to improve the scientific understanding of pharmaceutical processes (blending, granulation, milling, spray-drying, tableting  and coating processes in batch mode or in continuous mode) and formulations.   
  •   To create the framework and strategy for modelling of continuous manufacturing technologies.   
  •   To give support to Continued Process Verification / Validation, Process Performance Qualification.   
  •   To develop new technologies, new tools and new applications to optimize formulations, manufacturing processes enabling integrated CMC development.   
  •   To write and review scientific reports and manuscripts.   
  •   To follow up scientific literature  in order to create new development opportunities for pharmaceutical development.   

  • PhD in Pharmaceutical Sciences or in Engineering / Bio-engineering.  

Experience and skills:   
  • A minimum of 2 years professional experience in the pharmaceutical industry with a focus on drug product formulation and process development is a strong asset. 
  • Expertise in in-line PAT method development (NIR, Raman, particle characterization analyzers, softsensors, …). 
  •   Experience on the implementation of PAT in the context of CM is a plus.   
  •   Sound knowledge and understanding of off-line analytical reference methods (UPLC, LOD, laser diffraction, …).   
  •   Expertise in chemometric modelling using Matlab, SIMCA, JMP.   
  •   Experience with data alignment softwares such as SiPAT or Syn TQ is a plus.   
  •   Expertise in designing DoE and statistical analysis on JMP or MODDE.   
  •   Experience on developing control strategies is a plus.   
  •   Detailed understanding of NCE DP development including: formulation and process development, scale-up, technology transfer.   
  •   Knowledge on development risk assessment.   
  •   Knowledge on GMP and QbD regulatory requirements .   
  •   Communication, influencing and negotiation skills to represent the department internally and externally.   
  •   Demonstrated ability to coordinate and track activities.   
  •   Ability to work independently as well as within multidisciplinary teams in an international environment.   

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