Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vectors and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. At Exothera and Univercells, Our mission is to make life-changing therapies available 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 150+ people, fully supported by prominent investors and international organizations.
The Development and Manufacturing Technician is responsible for carrying out development and manufacturing of nucleic acids products (DNA, mRNA and LNP) by IVT, DSP and formulation operations. He / she will work within our development and GMP production activities in multi-products facilities (mRNA drug substances & drug products manufacturing and filling for development, clinical trials and commercial use).
The Development and Manufacturing Technician will be required to strongly collaborate with the Technical Lead, Technicians, Head of development and production, (senior) scientist, analytical science/ QC team, project leaders and QA.
- Schedule development and production process steps and equipment management,
- Execute a process development (nucleic acids process) based on experiment Protocol and help scientist for write the experiment report.
- Carry-out IVT, DSP, formulation manufacturing process and filling in compliance with EHS, cGMP, SOPs and manufacturing documentation requirements of development, clinical and commercial grade product:
- IVT and DSP: DNA and mRNA production based on a standardized and fully automated process
- Formulation : encapsulation of mRNA in Lipid Nano Particles, based on a standardized process.
- Filling of small mRNA batches for pre-clinical and clinical purpose.
- Keep clean and safe the working area by following established cleaning & housekeeping routines.
- Record all data and results in specified forms (paper and electronic) according to EHS & GMP rules, SOPs, Working Instructions and Good Documentation Practices.
- Troubleshoot and investigate deviations and unexpected events, and support CAPA plans.
- Write, update, and review WI’s, SOP’s, BR’s, BOM’s.
- Execute initial and routine qualification & validation related to manufacturing operations.
- Execute basic maintenance and calibration operations.
- Performs environmental monitoring as needed.
- Suggest and help implement improvements.
- Respect EHS rules and instructions
QUALIFICATIONS & EXPERIENCE:
- Bachelor’s degree in Life Sciences, Chemistry, biology field or equivalent competencies acquired through experience
- Minimum of 1 or 2 years in process development or GMP clinical/manufacturing activities.
- DNA/RNA experience is a must.
- Understanding of compliance and cGxP considerations.
- Team player with good interpersonal skills.
- Driven by curiosity, eager to learn more every day and to continuously improve processes and practices.
- Capacity to work autonomously.
- “Technical-manual intelligence”, practical sense.
- Enthusiastic and agile to work on a variety of projects in a multi-tasking environment.
- Ability to give confidence through technical mastery, rigor, and reliable results.
- Right First Time & Customer-oriented.
- Fluent in French, good understanding of English (read and written).