Biologics Drug Substance Project Leader – Phase 3 | Cross‑Functional

UCB; Eigenbrakel; Hybride; EUR 120 000 - 160 000; Plein temps

Résumé du poste

UCB is seeking a Biological Project Leader in Drug Substance to drive development from preclinical to Phase 3. You will lead multidisciplinary teams, manage integrated DS strategies, and ensure high quality scientific outcomes across CMC objectives.

You will collaborate with Clinical manufacturing, regulatory and QA teams, delivering projects on time in a hybrid work model at the Braine-l’Alleud campus. Strong English communication and leadership are essential.

Qualifications

• Master’s degree or PhD in a relevant scientific discipline.
• Minimum 8 years’ experience in CMC biological pharmaceutical development and process sciences.
• Minimum 5 years’ experience in biologics upstream or downstream process development.
• Proven success leading complex projects and influencing teams in a matrix organization.
• Strong project management, risk management, and stakeholder engagement capabilities.
• Excellent English communication skills with the ability to simplify complex scientific concepts.

Responsabilités

• Lead one Drug Substance biologics development project from preclinical through Phase 3 and support tech transfer.
• Represent Drug Substance activities within cross‑functional Technical Satellite Teams and stakeholder forums.
• Define and execute integrated Drug Substance development strategies aligned with CMC objectives.
• Coordinate and empower subject matter experts to deliver milestones on time and within budget.
• Identify, communicate, and manage project risks with mitigation strategies.
• Provide scientific leadership, drive continuous improvement, and support regulatory submissions.

Connaissances

Project management

Risk management

Stakeholder engagement

English communication

Formation

Master's degree or PhD in a relevant scientific discipline

Description du poste

UCB is seeking a Biological Project Leader in Drug Substance to drive development from preclinical to Phase 3. You will lead multidisciplinary teams, manage integrated DS strategies, and ensure high quality scientific outcomes across CMC objectives.

You will collaborate with Clinical manufacturing, regulatory and QA teams, delivering projects on time in a hybrid work model at the Braine-l’Alleud campus. Strong English communication and leadership are essential.