Drug Product Senior Scientist (BE)

le contenu du travail

Make your mark for patients

We are looking for a Drug Product Senior Scientist who has strong communication skills to join us in our Biologics Drug Product Development team, based in our Braine-l’Alleud (Belgium) OR Slough(UK) offices.

About the role

The Drug Product (DP) Senior Scientist will support our late stage development/clinical projects, during the process/product technology transfer, the scale-up, preparation of commercialization and BLA/MAA submission.

This includes development of biological drug product presentations and processes (from early – to late stage) and participation in the technology/product transfer to GMP Manufacturing/Fill & Finish sites (internal or external).

Who you’ll work with:

• Nora Sebestyen as your Manager and many others amazing colleagues.

What you’ll do:

• Review/author CMC documentation related to technical and GMP batch manufacturing and technology transfer.
• Define process parameters for technical, scale-up and GMP batches.
• Participate in GMP-related processes such as change control initiation, deviations and investigations.
• Participate in BLA/MAA and IMPD preparation as reviewer.
• Participate in cross-functional meetings with SMEs, partner departments and CMOs.
• Escalate of deviations/issues related to the development plans to the Technical Support Team as required.

Interested? For this role we’re looking for the followingeducation, experienceand skills

• Bachelor’s degree or master’s degree preferred.
• At least 5 years of experience in sterile drug product development and/or manufacturing within the pharmaceutical industry is required. Experience within the biopharmaceutical industry is an asset.
• Other requirements:
• Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aspetic conditions (such as vial, cratridge and pre-filled syringe filling).
• Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization. Good knowledge of cGMP.
• Other assets:
• Understanding of the issues and challenges of taking products from late stage development into commercialisation.
• Understanding of biologicals drug product manufacturing process and scale-up.
• Knowledge in primary packaging and regulatory requirements.
• Knowledge of analytical, preformulation and formulation development.
• Very good command in English (both written and spoken).
• Excellent communication, negotiation and team player skills are required as there will be significant contacts with internal groups and external stakeholders.
• Attention to details in order to investigate failure, improve process,…

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

Learn more about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.