Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus and viral vector production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors.
At Exothera and Univercells, our mission is to make health equally accessible to all.
We work every day on reinventing biomanufacturing processes and develop or integrate the next innovative technologies. With the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!! This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Jumet, you will join a collaborative team, full of passionate change-makers. You will be a key member of an international and dynamic team in a fast-growing and innovative organization of 230+ people, fully supported by prominent investors and international organizations (Bill & Melinda Gates Foundation, European Investment Bank, Major impact funds…).
For our development, clinical & commercial manufacturing plants, you will be responsible for managing filling projects set-up and operations (active biological substances and possibly final drug products manufacturing for clinical trials and commercial use). Operationally you will report directly to the Chief Operating Officer.
With your project, technical & operational expertise, you will strongly collaborate with process development, production process engineers, production, supply chain, quality control, quality assurance, CQV, maintenance & CAPEX teams.
Focused on filling activities, your key responsibilities will be to:
- Translate (and reinforce) commercial business cases into manufacturing strategy,
- Perform inception/feasibility/conception studies,
- Manage the projects execution (small & large scale, bags & vials, new technologies), including equipment & containers selection, qualification, validation, stability studies and start-up phases, until routine production,
- Oversee production operations, including planning preparation, follow-up, and optimization,
- Set-up, supervise, manage, and train filling technicians,
- Manage EHS & Quality,
- Support regulatory and customers audits, inspections, and visits,
- Lead continuous improvement & Operational Excellence initiatives
REQUIREMENTS / QUALIFICATIONS
- Engineer, MSc in Biotechnology or Process Engineering, or equivalent acquired through experience.
- 10+years of successful and relevant experience in biotech GMP manufacturing activities (Viral Vectors for Cell & Gene Therapy, Viral Vaccines, Vaccines), and including filling operations.
- Excellent track record on bioprocess Engineering, Technology Transfer and/or Project Management.
- Exposure to new plant set-up/qualification/start-up projects is a clear plus.
- Exposure to CDMO context is an asset.
- Inspiring leader, and team player, with strong demonstrated interpersonal skills.
- Right First Time & Customer-oriented.
- Excellent analytical and organizational skills, pragmatism, and positive critical thinking.
- Project certification (PMI, Prince2, Agile) is a clear plus.
- Resilience and agility in demanding environment.
- Fluent in English and French.