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 180+ people, fully supported by prominent investors and international organizations (Bill & Melinda Gates Foundation, European Investment Bank, Major impact funds…).
You will be responsible for the setting-up, start-up then management of routine manufacturing operations of our new COVID-19 vaccine manufacturing plant for the concerned subsidiary of Univercells. You will be in charge of all active biological substances and possibly final drug products manufacturing for clinical trials and commercial use. You will be responsible for compliance with quality and safety standards, within the allocated budget. You also act as a leader for continuous improvement.
Operationally you will report to the Head of Manufacturing of the subsidiary with whom you will share the Production Authority role as defined in the EU GMP regulation.
You will actively contribute to the achievement of our ambitious goals and build strong partnerships with:
- Our R&D, Univercells Technologies, and Manufacturing Teams ensuring state-of-the-art and disruptive development and manufacturing capacities, from engineering definition to operations start-up and routine manufacturing,
- Our Program/Project Managers, providing manufacturing insights and inputs during CAPEX projects,
- Our HR Team, recruiting, onboarding, managing, and developing a powerful manufacturing team: Buffer & Media Prep / USP / DSP / formulation / filling technicians, production process (MSAT) engineers, production supports (logistics/cleaning), technical administration, production team leaders,
- Our Plant Support Team, creating and maintaining reliable and thrifty processes,
- Our Quality Team, strongly collaborating to build and manage a fully GMP/cGMP/WHO compliant plant and supporting regulatory and customers audits, inspections, and visits,
- Our Supply Chain Team, developing and delivering agility and operational effectiveness,
- Our Procurement Team, strongly collaborating to build a reliable network (suppliers, experts, partners),
- Our Financial Team, efficiently translating operational realities into reliable financial projections and financial impacts with sound reactions,
- Our full Staff, acting as an ambassador of good manufacturing practices and operational excellence awareness across the organization.
REQUIREMENTS / QUALIFICATIONS
- MSc or Ph.D. in pharmaceutical or bio-engineering, or industrial pharmacist, is required.
- 10+ 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 a must.
- Exposure to an international structure is a clear plus.
- Inspiring leader, with strong, demonstrated interpersonal skills.
- High level of initiative & strong ability to autonomously define vision, strategy, implementation plans, prioritize actions, and goals.
- 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.
We offer a long-term contract, a competitive salary package (health insurance, company car, pension plan, meal vouchers…), and the possibility of evolution in an international, dynamic, and fast-growing company. Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now!