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

Biopharmaceutics Project Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  69855

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 Pharma Sciences department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: Biopharmaceutics Project Lead.

 

As a UCB Biopharmaceutics Project Lead, you like to work in an environment where you can:

  • Apply biopharmaceutics tools and knowledge to identify risks to in vivo performance and drive the development of patient-centric development of drug products, across all phases of development from discovery to lifecycle management.
  • Develop and apply physiologically-based biopharmaceutics models (PBBM) to assess risks to in vivo performance and guide formulation development.
  • Represent the biopharmaceutics team in drug projects, including active participation in the Pharm Sci project team and interactions with colleagues in other functions (e.g. QP&DMPK) to develop the biopharmaceutics strategy (including bridging strategy and biopharmaceutics aspects of QbD), and input into development of the project CMC and clinical plans.
  • Be an active member of the biopharmaceutics and modelling communities at UCB and contribute to the continued development and deployment of UCB’s biopharmaceutics capabilities, including representing UCB in external collaborations and external expert groups.

 

 

As a UCB Biopharmaceutics Project Lead, you will contribute by:

  • Applying biopharmaceutical tools to identify risks to in vivo performance and driving patient-centric development of drug products, applying own expertise and leveraging the wider capabilities of the internal biopharmaceutics community and external experts as appropriate.
  • Representing the biopharmaceutics community and Product Development during internal and external meetings and interactions with key stakeholders.
  • Developing collaborative relationships with other departments within and beyond Pharm Sci (e.g. QP&DMPK, iADME), and with key external experts as appropriate.
  • Developing and applying PBBM/PBPK to identify risks and limitations to drug absorption and using the outcomes to influence the selection and development of most appropriate formulation and the project CMC and clinical plans (e.g. regarding BE risk, factors that may cause in vivo variability, etc).
  • Mechanistically assessing and interpreting preclinical and human pharmacokinetic data for drugs in early and late development through generation of PBBM models.
  • Defining and driving the generation of critical BP knowledge (in vitro and in silico) supporting DP development throughout the life cycle of the product.
  • Developing the project biopharmaceutics strategy, including formulation bridging strategy and obtaining buy-in from key stakeholders (Pharm Sci/Dev Sci).
  • Developing strategy to demonstrate clinical relevance of the control strategy for marketing applications as part of the project QbD strategy and obtaining buy-in from key stakeholders.
  • Applying BioRAM tools for holistic risk assessment and to identify key risks and knowledge gaps, and using this to help drive project discussions and strategy.
  • Leveraging BP knowledge for early anticipation of life cycle management opportunities or early review of Target Product Profile.

 

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

Technical skills:

  • PhD in Biopharmaceutics, Pharmaceutics, Pharmacokinetics, or related field and 2+ years of industrial or postdoctoral experience.
  • Skilled in physiologically-based biopharmaceutics modelling (PBBM) and application in the context of formulation development.
  • Skilled in design of clinically relevant dissolution and project biopharmaceutics strategies, including formulation bridging and clinical relevance.
  • Knowledge of biopharmaceutics in vitro models and application in the context of formulation development.
  • Knowledge of different formulation types, with particular focus on their absorption properties.
  • Knowledge of pharmacokinetics and experience in interpretation of data from human and preclinical species.
  • Knowledge of the design and impact of clinical studies used for formulation understanding (e.g. relative bioavailability, BE).

 

Soft skills:

  • Strong communication and influencing skills and collaborative mindset.
  • Works and leads independently, with a proactive, self-initiative, self-motivation and self-strategic direction.
  • Provides scientific leadership within area of expertise to project team
  • Strong planning and organization skills.
  • Ability to lead, drive and work with external partners.
  • Continuous learning mindset.
  • Fluent in English.

 

 

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. 

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