Make your mark for patients
We are looking for a Transversal Analytical Lifecycle Expert who is analytical, collaborative, and detail-oriented to join our Analytical Lifecycle Expertise & Integration team, part of Patient Supply QC organization, based at our UCB campus located in Braine-l’Alleud, Belgium.
About the role:
You will focus on Analytical Method Lifecycle Management for UCB Commercial Products in a transversal (cross-sites & cross-functional) position.
Who you will work with:
You will work closely with the Industrial Analytical Program team, the Analytical Development Science team, the Patient Supply QC teams, Sites QC teams and Global Quality Assurance teams.
What you will do
1. Trend and monitor analytical method performance by collecting data, identifying trends, and documenting the outcomes in reports.
2. Lead Transversal Analytical Committees to review trends, define and prioritize actions, and ensure proper actions follow-up.
3. Lead Invalid Trend analysis by establishing method invalid rates, evaluating QC lab signals, driving committee decisions and documenting outcomes in reports.
4. Execute Analytical Method Performance Verification (AMPV) program, including risk assessments, action plans definition, reporting and follow-up.
5. Monitor QC release parameters by managing alerts, investigations, and reporting within the CPV framework.
6. Drive transversal troubleshooting and remediation activities, ensuring clear definition, coordination, communication and follow-up with stakeholders.
7. Manage quality system activities (deviations, investigations, CAPAs, change controls).
8. Support or lead cross-functional risk management and continuous improvement initiatives.
9. Contribute to or lead transformational projects to harmonize analytical lifecycle processes.
Interested? For this role, we are looking for the following education, experience, and skills:
10. Master’s degree with 3+ years in analytical roles in the biopharmaceutical industry.
11. Strong expertise in analytical techniques (chromatography, biological assays, spectroscopy, mass spectrometry, microbiology).
12. Solid understanding of CMC and analytics for late-stage/commercial products;
13. Knowledge of quality and regulatory aspects is a plus.
14. Strong project management and problem-solving skills, with experience in troubleshooting.
15. Data-driven mindset with ability to assess risks and justify decisions.
16. Excellent communication and stakeholder management skills in complex, cross-functional environments.
17. Collaborative mindset with a focus on continuous improvement.
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!