Requirements: English
Company: EPM Scientific
Region: East Flanders , Flanders
A biotech company is seeking an experienced leader to oversee late-phase clinical manufacturing of biologic''s at external partners. This role involves managing internal project teams and acting as the primary liaison with CDMOs, ensuring successful tech transfer, process validation, and regulatory readiness for live bacterial vaccine products.
Key Responsibilities:
- Lead external manufacturing projects, including on-site oversight during critical activities.
- Manage and mentor a team of project managers.
- Oversee tech transfer, process validation (PPQ), and clinical batch production.
- Ensure GMP compliance and support regulatory submissions (Module 3 of CTD).
- Collaborate with QA and regulatory teams to prepare for inspections and filings.
- Drive internal CMC initiatives and continuous process improvements.
Requirements:
- PhD or Master''s in life sciences, biotech, or engineering.
- 15+ years in biologics manufacturing, preferably in sponsor-side roles.
- Strong expertise in PPQ, BLA submissions, and regulatory standards (FDA/EMA).
- Experience with fermentation, aseptic filling, lyophilization; live bacterial products preferred.
- Excellent leadership, communication, and project management skills.
- Fluent in English
Education and Competences:
- PhD or Master''s degree in life sciences, biotechnology or Engineering, or equivalent by experience.
- Minimum of 15 years of experience preferably in a sponsor company overseeing outsourced manufacturing activities of biologics.
- Demonstrated experience with Process Performance Qualification (PPQ) and successful Biologic License Applications (BLAs).
- Expert knowledge of technical, quality and global regulatory requirements, specifically US FDA and EMA, for Phase 3 and commercial production, launch, and post-marketing requirements.
- Ability to lead, develop and motivate cross-functional teams.
- Strategic thinking and flexibility to integrate technical requirements.
- Autonomous and adept at pragmatic and risk-based decision-making.
- Excellent organizational and communication (verbal and written) skills.
- Fluent in English, written and spoken. Knowledge of Spanish or Portuguese is a plus.