Senior Scientist - Braine-l'Alleud, België - UCB S.A.

UCB S.A.

Geverifieerd bedrijf

Braine-l'Alleud, België

3 weken geleden

Geplaatst door:

Sophie Dubois

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Beschrijving

Make your mark for patients
We are looking for a Senior Scientist (Biological Formulation Development) who is curious and communicate well to join us in our Biological Commercial Formulation Development (BCFD) team, based in Braine-l'Alleud, Belgium

About the role, your main responsibilities are:

To provide technical and scientific support in the management/coordination of biological drug product development.
To define and select drug product formulations and support CMC preclinical and clinical activities.
To drive all activities related to formulation modelling and design and where required, to assist in partnering activities at other sites/locations (internal or external).

Who you'll work with:

Claude Peerboom as your manager.
Your 2 direct reports (scientists).
Many other internal and external partners at transversal level.

What you'll do:

Performing experiments/analyses and other enabling studies to support nonclinical studies, early phase, late phase.
Supporting preformulation laboratory activities, which include laboratory set up, provision of technical resources, generation of SOPs and other GSP related documentation.
Designing formulations, which include excipient stabilization, protein stabilization technologies, robustness verification, optimization and lyophilization development through preformulation and longterm stability studies.
Designing product development studies (freezethaw studies, shear studies, filter studies...) necessary to support the transfer of drug product to clinical trials manufacturing sites.
Providing support to Drug Product and Devices by developing new formulation in order to address the needs and requirements of both these groups. Investigate new routes of administration (i.e. inhalation, oral), or new presentation when requested.
Building molecule & drug product understanding throughout development by determining biochemical degradation pathways through the generation and interrogation of analytical data. Understanding of chemical degradation routes (pH, buffer, light, oxygen etc.) and physical degradation routes (aggregation, precipitation, denaturation, adsorption etc.)
Establishing a scaledown model of clinical/commercial filling operations

Interested? For this role we're looking for the following education, experience and skills

University Degree (Master or PhD preferred) in biology, biochemistry, analytical chemistry or equivalent by experience.
At least 5 years of experience in preformulation / formulation / drug product manufacture and / or analytical experience within the biopharmaceutical industry is required.
A comprehensive understanding and knowledge of the issues and challenges of taking products coming from research through development and the associated processes and clinical manufacture is required.
Good knowledge of cGMP and regulatory requirements at early stage of development.
Very good command in English (both written and spoken), French is a plus.

Soft skills:

Good communication and negotiation skills are required as there will be significant contacts with internal groups and external contractors.
Ability to liaise / coordinate with academia in order to build collaborative partnerships.
Being curious in taking new initiatives.

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.