Gene Therapy PCMD (Senior) Scientist

Jobinhalt

Make your mark for patientsWe are looking for a Gene Therapy Physico-Chemical Method Development (Senior) Scientist who is team and solutions oriented to join us in our CMC Gene Therapy Analytical Development team, based in Braine-l’Alleud, BelgiumAbout The RoleThe 2 main objectives of the Gene Therapy (GT) Physico-Chemical Method Development (Senior) Scientist are:

• To identify and to implement high throughput analytical tools supporting the release and stability of multiple therapeutic gene therapy programs throughout clinical phases (from phase 1 to readiness to launch).
• To develop, validate, tech transfer (to internal or external partners) and execute fast and reliable physico-chemical assays to support the clinical development of AAV-based Gene Therapy Products in accordance with current rules and procedures ( e. GMP/GSP)

Who You’ll Work With

• Michel Degueldre as your Manager and other amazing colleagues at transversal and global level.

What You’ll Do

• Support release and stability testing of Gene Therapy Products by developing, validating, coordinating, executing and/or tech transferring fast, reliable and QC friendly physico‑chemical assays.
• Contribute and potentially lead assay development, drive results.
• Cross-train and provide support for upstream/downstream operations, in-process analysis, characterization and vector biology teams ( e. Vector Core, Boston).
• Provide high quality documentation (procedures, protocols, reports) of all technical work performed in the lab in accordance with data integrity requirements.
• Verify data (double check, data check).
• Participate to the result analysis and trending.
• Present/discuss results in team meetings.
• Prepare written procedures and instructions.
• Sustain scientifically current (state of the art) laboratory environment and/or data systems.
• Work independently and cross functionally across various UCB teams related to analytical activities.
• Manage priorities and engage/communicate in a multidisciplinary environment. Support the development of the UCB GT strategy internally as well as externally ( e. CMOs/CROs).

Interested? For this role we’re looking for the following education, experience andskills

• Master’s degree preferred in Analytical Chemistry, Biochemistry or equivalent with at least 3 years of professional experience within the biopharmaceutical industry.
• Previous development and validation of methods experience is mandatory; for viral vector products is a plus.
• Ability to operate the following techniques: capillary electrophoresis and/or liquid chromatography and/or dynamic and static light scattering.
• Strong and proven laboratory and statistical skills.
• Strong and proven experience in a regulated laboratory environment ( g. GLP/GMP).
• Strong and proven expertise in physico-chemical method development with hands-on experience developing biophysical based methods for viral vectors, protein or impurity quantification.
• Deep understanding of characteristics to be considered for the validation of the most common types of analytical methods.
• Mastering statistical tools supporting the development of analytical methods. Knowledge of total error approach is a plus.
• Mastering regulatory requirements and HSE/Biosafety rules.
• Good knowledge of English and ability to read, analyze, and interpret common scientific journals.

Soft Skills

• Ability to think critically and demonstrate troubleshooting and problem-solving skills (identify problems, collect and analyze data, establish facts, and draw valid conclusions).
• Well organized, flexible, meticulous and rigorous (data integrity oriented).
• Ability to integrate new concepts and to work in a multicultural environment as well as to adopt an efficient and independent way of working in a changing environment.
• Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
• Team spirit oriented and able to offer/receive constructive feedbacks.

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 UsUCB 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.