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 new COVID-19 vaccine manufacturing plant, you will be responsible for the successful tech transfer and manufacturing optimization of biopharma process (active biological substances and possibly final drug products manufacturing for clinical trials and commercial use).
You also act as a leader for the process continuous improvement.
Operationally you will report to the Head of Production.
With your project and technical expertise, you will be required to collaborate with process development, production, quality control, quality assurance, CQV, maintenance, engineering, and project/program managers.
Your key responsibilities will be:
- Lead tech transfer projects related to manufacturing processes (buffer/media preparation, preculture, USP, DSP, IPC, cleaning, sterilization, decontamination) from scratch or based on existing processes:
- Interface with process development,
- Technology transfer,
- Mastering & application of science & risk-based approaches (QBD, DoE, Control Strategy…),
- Process Performance Qualification, Cleaning & Process Validation, Continuous Process Verification,
- Implementation in conformity with customers & GMP requirements,
- As production front line, support teams for process troubleshooting, continuous improvement and technical discussion with prospects/clients:
- Data trending and monitoring of running processes to ensure process reliability,
- Determination of product impact in case of significant investigations/deviations/OOS related to the production process,
- Production team training & coaching,
- Support for changes to existing production processes by generating scientific / technical study protocols and reports,
- Identify, assess, and implement new technologies to continuously improve production performance: product quality, reproducibility, reliability, cost, and time of manufacturing processes.
- Perform technology and business intelligence on the market to maintain level of expertise.
- Assess the needs for new equipment, establish URS and select suppliers in collaboration with relevant internal teams.
- Manage project constraints (cost, quality, time, scope, risks, expected benefits).
- Perform risk assessments.
- Maintain, adjust, and provide knowledge data basis, documentation and operating instructions related to production process.
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).
- Excellent track record on bioprocess development, Technology Transfer and/or MSAT.
- Exposure to new plant setting-up/qualification/start-up projects is a clear plus.
- 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 a demanding environment.
- Fluent in English and French.