Job description
Mission
Lead critical technology transfer of a commercial oral solution product to an external CMO, ensuring uninterrupted patient supply. This role combines strategic project ownership with deep technical manufacturing expertise in a high-stakes, multi-stakeholder environment.
Your Impact
* Patient Supply Continuity: Ensure seamless manufacturing transition without supply disruption
* Technology Transfer Leadership: Drive complex oral solution transfer to external CMO
* Cross-functional Orchestration: Lead multidisciplinary teams across QA, Regulatory, Analytics, and Manufacturing
* External Partnership Management: Act as primary technical interface with CMO partners
Daily Responsibilities
* Project Leadership: Own end-to-end technology transfer project plans, timelines, budgets, and deliverables
* Technical Expertise: Serve as go-to authority for oral solution manufacturing (mixing, filling, IPCs, validation)
* Documentation Excellence: Author/review tech transfer files, protocols, validation reports, and regulatory submissions
* Stakeholder Management: Coordinate internal teams and external CMOs through complex investigations and troubleshooting
* Risk Mitigation: Lead manufacturing investigations and implement corrective actions to prevent supply disruption
* Virtual Collaboration: Conduct regular CMO meetings (Teams/English) to drive project milestones
Must-Have Requirements
* Experience: 5+ years pharmaceutical manufacturing (8-10+ preferred for complexity)
* Technical Mastery: Deep expertise in oral solution drug product manufacturing - non-negotiable
* Technology Transfer: Proven track record in tech transfer and process validation
* Project Management: Demonstrated ability to manage complex, multi-stakeholder projects
* Quality Systems: Strong understanding of GMP, regulatory requirements, and quality systems
* Language: Fluent French (spoken/written) - essential for stakeholder communication
* Leadership: Senior, autonomous profile capable of challenging CMOs and driving decisions
* Investigation Skills: Expertise in complex manufacturing troubleshooting and root cause analysis
Preferred Assets
* Language: English fluency for international collaboration
* UCB Experience: Familiarity with tools, SOPs, and processes
* CMO Expertise: Previous work with external manufacturing organizations
* Financial Acumen: Understanding of Opex, Capex, and COGS impact
* Virtual Labs: Experience managing third-party laboratory investigations
Team Context
* New Team: Recently established MSAT Pharma team (late 2024/early 2025) in fast-evolving structure
* Size: 9 people expanding to 10
* Role: Internal manufacturing expert support - "second-line troubleshooting" and technology transfer leadership
* Collaboration: High interaction with QA, Regulatory Affairs, Analytics, and external CMOs
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.