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Clinical Formulation Scientist - Belgium  

UCB (company)


Posted on : 02 February 2017

Project Description

 Who Are We:
  • We put 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. 
  • To strengthen our Formulation and Process Development team, we are looking to fill the position

Nature and scope: 
  • Support the overall work in the D4P organization (ex CPhD), e.g. by supporting D4P strategy, by taking responsibilities for continuous improvement and operational excellence initiatives. 
  • Actively provide strategic guidance for initiation and management of all NCE R&D development programs 
  • Manage all quality, scientific and technical aspects of internal pharmaceutical development activities 
  • Ensure a proper and timely evaluation of NCE pharmaceutical formulation and its manufacturing process from FIH clinical stage to market launch 
  • Ensure an efficient and effective support of CMC activities in coorporation with internal and external customers   
Major Accountabilities
  • To contribute to department mission and strategy 
  • To contribute to our strategy in moving our company to a biopharma leader position
  • To develop and establish a continuous improvement mindset in order to ensure state-of-the-art products and processes 
  • To develop proactively creative and efficient solutions for IP protection of Drug Product and Manufacturing processes   

  • To plan and perform clinical formulation and process development activities by executing from laboratory (e.g. 1-100 grams) to large-scale experiments (few kgs) alone or with the support of technical staff, by providing appropriate documentation and by performing the analysis of data/ results. 
  • To support the manufacturing of formulations for analytical testing, stability assessment and clinical trial supplies. 
  • To write development/ technical reports in the context of pharmaceutical development according to department internal policies. 
  • To analyze process data and develop suitable manufacturing processes compliant with cGMP requirements. 
  • To apply all relevant regulations, guidelines and operating procedures (quality and safety) in the laboratory work, qualification and validation activities and      manufacturing of formulations. 
  • To be responsible for some instruments/ equipment according to the qualification/validation master plan as assigned (incl. some contribution to qualification work, 1st level maintenance, daily calibration, …etc). 
  • To support and issue working instructions, Standard Operating Procedures in the field of expertise as assigned. 
  • To be responsible for the technical/scientific supervision of staff assigned (e.g. formulation technician, contractors). 
  • To ensure in cooperation with the manager being appropriately trained for the tasks assigned. 

Expertise & Skills:   
  • Min 3-5 years experience (maybe as part of the education) in formulation/process development, scale-up and analysis in the field of clinical development (e.g. solid dosage forms). 
  • Good understanding of the technical issues that arise during formulation/process development and demonstrated ability to offer solution oriented proposals (e.g. tabletting, wet granulation, spray drying, nanomilling). 
  • Skilled in analytical techniques common to a pharmaceutical laboratory and in formulation development support. 
  • Knowledge of GXP principles and good understanding of regulated environment (GLP/GMP). 
  • Demonstrated ability to continuously update knowledge in all relevant areas of early pharmaceutical development and non-clinical support 
  • Can work in virtual teams while appreciating different cultures/countries/companies 
  • Coordinates internal activities in his/her own department for projects. 
  • Strong planning and organisation skills, including ability to set priorities. 
  • Demonstrates an ability to help team and others to solve problems 
  • Provide scientific leadership within specialist area to project team. 
  • Gives input based on his/her own expertise 
  • Demonstrates an ability to lead, drive and work with external partners.  
Job Segment:  Clinic, Scientific, Medical Lab, Scientist, Pharmaceutical, Engineering, Healthcare, Science