Early Phase Scientist (Bio Drug Product Development)

Job content

To strengthen our Bio Drug Product Development & Manufacturing (DPDM) Team, we are looking to fill the position of: Early Phase Scientist (Bio Drug Product Development)

As an Early Phase Scientist you will support our early stage development/clinical projects.

This includes:

• Technical support of biologics in the establishment of robust, fit for purpose biologicals drug product manufacturing processes for early development phases.
• Support activities for defining and selecting drug product manufacturing processes and components for support to clinical manufacture (for early stage projects, e.g. support activities for pre-clinical, stability, phase 1/2).
• Support the technology transfer activities for early phase drug product manufacture at external CMOs.
• Transfer knowledge on early phase drug product development projects to the late stage Bio Drug Product (DP) Development Team.
• Build close collaboration with the Bio DP Tech Transfer and Manufacturing Team for the establishment of drug product processes and manufacturing of stability and clinical DP batches.
• Support the development and implementation of the systems and processes for the DP CMC development strategy within DPDM.

You will more precisely contribute by:

• Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or others.
• Provide all appropriate support to drug product process development activities (e.g. extractable volume assessment, target fill volume assessment, compatibility assessments, clinical blinding).
• Provide support to ensure timely delivery of stability and clinical trials DP batches.
• Ensure products are manufactured in accordance with UCB quality system, cGMP and latest regulatory requirements.
• Preparation of protocols and reports in relation to drug product technology transfer and development activities.
• Build close collaboration with the Bio DP Tech Transfer and Manufacturing Team for the establishment of drug product processes and manufacturing of stability and clinical DP batches.
• Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes.
• Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities.
• Ensure efficient knowledge transfer from early phase development to late phase development.

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

• Bachelor’s Degree preferred.
• Minimum 2-3 years experience in drug product development and sterile manufacturing within the biopharmaceutical industry is required.
• An understanding of the issues and challenges of taking products coming from Research to development process and into clinical manufacture is required.
• Good knowledge and technical experience in parenteral liquid and lyophilized product development and cGMP manufacturing under aseptic conditions would be required.
• Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization.
• Good knowledge of cGMP and regulatory requirements.
• Knowledge of analytical, pre-formulation and formulation development.
• Understanding of antibody drug product manufacturing process and scale-up.
• Fluent in English (written & spoken).

Soft skills:

• Excellent communication skills in order to build strong networks with internal and external stakeholders.
• Strive for Process Efficiency Improvements.
• Team Player while being able to work autonomously and prioritize workload per project requirements.

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.