Here, in Nivelles (Belgium), you will join a collaborative team full of passionate change-makers. You will be the actor of the successful development of a smart and innovative RNA vaccine production process. You will select and implement the process steps to generate crude and purified RNA bulk vaccine. You will supervise the in house and outsourced analytical activities linked to the RNA candidate vaccine.  With your team covering USP, DSP and analytical activities, you will develop the Drug Substance production process and transfer it to the Manufacturing unit.

RESPONSIBILITIES 

  • Design and implement experimental plan for Drug Substance (USP, DSP and analytics) production process development.
  • Lead the operational development team of RNA vaccines.
  • Contribution to and supervision of the experiments in the lab. 
  • Plan and anticipate needs of consumables and equipment’s.
  • Process transfer from external partner.
  • Analytical assays outsourcing.
  • Management of documentation related to experiment (Protocols and report writing).
  • Results analysis and presentation.
  • Traceability of performed operational work through recording of all data and results in specified forms (paper and electronic) with accuracy and accountability.
  • Interaction with and support to the Project Managers
  • Correct use and tracking of quality system within the field of activities (procedures/checklist/working instructions, etc.)
  • Adherence to standard operating procedures in all the operational tasks executed.
  • Identification and reporting of deviations from standard operating procedures and of unexpected events through initiation of related investigations
  • Support of corrective and preventive actions related to deviations and unexpected events
  • Contribution to general lab activities (housekeeping and maintenance)
  • Generation of process quality documentation (procedures, work instructions, templates, etc.)


REQUIREMENTS / QUALIFICATIONS


  • PhD in Molecular Biology.
  • Minimum 5 years of experience in the field.   
  • Experience in RNA synthesis processes is a plus.
  • Strong sense of observation and capability of troubleshooting
  • Resistance to stress and flexibility (adaptability to a changing and multi-tasked environment)
  • Enthusiasm and agility to work on a variety of projects and to learn more every day
  • Strong organizational skills, proactivity, scientific curiosity, desire to be impactful
  • Capability to work in a cross-functional and multi-cultural team
  • Fluent in English (written and spoken)