Biopharmaceutics Project Lead

仕事内容

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

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, experienceandskills:

• Master’s degree or PhD preferred in Biopharmaceutics, Pharmaceutics, Pharmacokinetics, or related field and at least 2 to 4 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).
• Very good command in English.
  

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.
  

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 is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

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. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.