Xna Process Development Technician
Il y a 6 mois
**OUR ORGANIZATION**:
At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through 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”
Univercells SA brings together a group of Belgian and global biotech affiliates working together under a common mission (the “Group”). Each division of affiliates operates a different part of the healthcare value chain, through a distinct business model:
- Exothera is a Contract Manufacturing and Development Organization (CDMO) for biologicals, mainly vaccines and viral vectors, with GMP production facilities in Belgium and offering process development and optimization services.
- Unizima delivers international project management of technology transfer, alongside operational support services (quality, supply chain, digital) and bioproduction training programs, as well as care centers and diagnostics surveillance centers.
- Quantoom Biosciences develops open, integrated and affordable manufacturing platforms (RNA as flagship) to enable the production of vaccines & therapeutics that scale from development to mass production.
- RLM Consulting thanks to a substantial knowledge of the pharmaceutical industry and a strong scientific background, RLM Consulting provides international regulatory affairs support at all stages of product development, from discovery research through preclinical and clinical testing, up to and beyond submission of the dossier for marketing authorization
We deliver excellence and strive for innovation thanks to collaborative teams of passionate change-makers. We are driven by 5 core values in everything we do: Accountability, Continuous Improvement, Teach & Lead, Integrity, and Team spirit.
Based in Andover you will join, a collaborative team full of passionate change-makers and you will have the exciting opportunity to participate in the start of activities in the US.
**MISSION**:
As a process development technician, you will be responsible for producing DNA, mRNA, saRNA, LNP (formulation) including DSP (downstream process) technology (such as UF, Chromatography, filtration) under the responsibility of a Scientist. You will also be required to strongly collaborate with the technical lead, the head of development and production, analytical sciences; the technical team, and QA.
**RESPONSIBILITIES**:
- Schedule production process steps and equipment management,
- Assemble, prepare, check equipment and/or production materials,
- Carry-out production of xNA with EHS, SOPs and R&D documentation requirements of development:
- USP and DSP: DNA and mRNA/saRNA production based on a standardized and fully automated process
- Formulation : encapsulation of mRNA/saRNA in Lipid Nano Particles, based on a standardized process.
- Filling of small mRNA/saRNA batches for 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 & R&D rules, SOPs, Working Instructions and Good Documentation Practices.
- Troubleshoot and investigate deviations and unexpected events, and support CAPA plans.
- Write, update, and review EP (experimentals protocols), RP (reports protocols) and BOM’s.(Bill of materials)
- Execute basic maintenance and calibration operations.
Suggest and help implement improvements.
- Respect EHS rules and instructions
- Collaborate with employer, EHS department and hierarchical line in: performing risk analysis, accident/incident investigations, proposal of preventive/corrective measures regarding to avoid risks.
- Attend the EHS training sessions organized
- Flag up risks and unsafe situations
**QULIFICATIONS**:
- Bachelor’s degree in Life Sciences or equivalent competencies acquired through experience.
- 5 years of successful and relevant experience in Development activities.
- 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 able 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.
- Fluency in English; basic knowledge of French is a plus.
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