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

Principal / Senior Scientist, Drug Product Process Design and Development for Biologics

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Laboratory Support
Job ID:  67150

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 Biotech Sciences team, based in Braine, Belgium we are looking for a talented individual to fill the position of: Principal / Senior Scientist, Drug Product Process Design and Development for Biologics. 


As a Principal / Senior Scientist, Drug Product Process Design and Development for Biologics, 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:

• Support our late stage development / clinical projects, during the preparation for commercialization. This includes development of biological drug product presentations and processes (from early – to late stage) and participation in the transfer to GMP manufacturing / Fill & Finish sites (internal or external).

• Co-ordinate or contribute to a small matrix-type drug product team within the “Drug Product Process Design and Development (DPPDD)” group, focused on supporting a late stage Biological project.

• Represent the group as the Technical Solutions Team (TST) Representative for all related aspects of the project. 
 
You will contribute by:  
Process Development accountabilities:  

• Defining and executing work packages related to development of the Drug Product presentations and manufacturing process, fit-for-purpose for clincal phases 1-3, and support filing preparations 
 
Project (-management) accountabilities:

• Building of the drug product (DP) strategic development plan

• Conducting yearly resource forecasting based on defined work packages and assessing additional resource needs when project requirements change • Supporting the creation of the project budgets (CAPEX & OPEX) for the TST

• Developing the 5 Year project plan for DP, in alignement with formulation- and packaging teams

• Tracking all ongoing activities for the DPPDD team members on the project 
 
Matrix team (-management) accountabilities:  

• Coordinating in a matrix environment a team of DP Subject Matter Experts (SMEs)

• Co-ordinating pre- and post- TST meetings with DP SMEs - ensuring that all relevant project information is collated and shared at the TST and providing feedback to DP SMEs from the TST 
 
Technical Documentation:

• Accountable for CMC documentation (reports, FMEA, …) as either author or reviewer  
 
Communication:

• Communication of DP strategy and status of plans to the TST

• Communication of overall project strategy from the TST to SMEsS and DP -  and  Biotech Clinical Manufacturing Sciences (BCMS) Leadership Teams • Timely escalation of risks / issues / deviations related to the development plans to the project – and leadership team, as required 
 
Other:

• Leading and / or contributing to failure investigations and impacting assessments of DP manufacturing processes at clinical and commercial Fill & Finish Facilities (Internal and external) 
  
Interested? For this position you’ll need the following education, experience and skills:  
 • Bachelor’s Degree or Master’s degree expected / PhD preferred

• Minimum 3 years experience in drug product development for Biologics, and steriles manufacturing within the biopharmaceutical industry

• An understanding of the issues and challenges of taking products from late stage development into commercialisation

• Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under asepetic conditions

• Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization

• Knowledge in primary and secondary packaging

• Knowledge of analytical, preformulation and formulation development is an asset

• Excellent communication skills

• Team player

• Strong ability to work autonomously and prioritize work packages as per project requirments, capable to build strong networks with internal- and external stakeholders

• Project management skills  

• Strive for process efficiency improvements, waste reductions and cost improvements 
 
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. 

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