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Sr Planning-Admin RA Downstream Processing (DSP) Ghent Belgium,  

Ablynx (company)


Posted on : 09 November 2018

Project Description

job description

the Downstream processing (dsp) team (~ 25 people) within the Chemistry Manufacturing and control (cmc) Pharmaceutical Development & technology department at ablynx, a sanofi company, is looking for an experienced Planning-admin ra.

the Downstream processing team within ablynx is responsible for:

  • generic purifications to deliver cmc grade nanobody batches to support all projects running in ablynx
  • development of dsp processes for clinical nanobody® development candidates during pre-Clinical Development
  • large-scale dsp activities (Purification of tens to thousands of grams), including in-house production of non-GMP ds for Toxicology (tox) studies
  • dsp-related activities to support late-stage projects (e.g. par studies, process Validation (small-scale model Qualification and Validation).
  • dsp platform improvement and new technology exploration and implementation

 

responsibilities

  • main responsibility: weekly Planning of the generic purifications:
      • together with upstream processing (usp) planner and using knowledge and skills of Chromatography and filtration (depth and tangential flow filtration), plans in the different generic purifications in a realistic and timely manner so that requested timelines and quantities are achieved by the different operators.
      • provides overall production and Purification Planning to the different requestors and project leaders
      • keeps the different administrative work flows (LIMS; bio-repository; electronic workbook for qc overviews) associated with the dsp Planning up to date assuring that operators can perform purifications in a timely and organized manner
      • provides general support in the Lab and – if needed - interacts with the dsp responsible of the project (e.g. in case of technical issues)
      • discusses weekly dsp Planning with the different team leaders
      • presents Planning during weekly dsp Planning meeting to the rest of the team
      • captures and writes meeting minutes for the weekly dsp meeting
  • in case of delays or technical failures, pro-actively notifies requestors and – together with usp planner – plans in follow-up productions and purifications
  • is responsible for transfer of aliquots to the requestor once the batch is declared fit-for-purpose

 

  • other responsibilities may include: coordination of technical Training for newcomers, coordination of Research associate Lab meetings, consumables stock organization: SAP decentral requisitioner to purchase consumables and equipment.

 

profile

the candidate should:

  • have sense for initiative, quality and accuracy
  • have the ability and desire to work in a fast-paced, dynamic environment
  • be a team player, enthusiastic and flexible

Locations

Ghent Belgium

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