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 +200 people, fully supported by prominent investors and international organizations (Bill & Melinda Gates Foundation, European Investment Bank, Major impact funds…).
For our new COVID-19 vaccine manufacturing plant, you will ensure the daily management and monitoring of production activities, and the management of your team and your production areas. You will be in charge of active biological substances and possibly final drug product manufacturing for clinical trials and commercial use.
You will be responsible for the compliance with quality and safety standards, within the allocated planning and budget. You also act as a leader for continuous improvement.
Operationally you will report to the Head of Production.
With your managerial and technical expertise, you will be required to collaborate with production technicians, laboratory technicians, Process Engineers, Quality Control, maintenance, supply chain, CQV, QA, project/program managers, and CAPEX teams.
Your key responsibilities will be:
- Setting-up, start-up then management of production routine operations: buffer/media preparation, preculture, USP, DSP, IPC, cleaning, sterilization, decontamination, logistics,
- Production planning preparation, follow-up, and optimization,
- Staff setting-up, supervision, management, and training,
- EHS & Quality management,
- Support during regulatory and customers audits, inspections, and visits,
- Continuous improvement & Operational Excellence.
REQUIREMENTS / QUALIFICATIONS
- Bioengineer, industrial pharmacist, MSc or equivalent acquired through experience is required.
- 5+years of successful and relevant experience in biotech GMP manufacturing activities (Viral Vectors for Cell & Gene Therapy, Viral Vaccines) is a must.
- An excellent track record of managing diverse operational teams is a must.
- Exposure to setting-up/qualification/start-up/tech transfer projects is nice to have.
- An inspiring leader, with strong, demonstrated interpersonal skills.
- Right, First Time & Customer-oriented.
- Excellent analytical skills, pragmatism, and positive critical thinking.
- Resilience and agility in a demanding environment.
- Fluent in English and French.