Sr Planning-Admin RA Downstream Processing (DSP) Ghent Belgium,
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
- 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
- acts as liaison between the production & Purification requestor and the Analytics department to ensure that the quality of the nanobody batches meets the requirements for In Vitro or In Vivo Applications
- 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.
the candidate should:
- have a degree b. sc. or m. sc. in Biotechnology/(bio)Chemistry/pharmacology/industrial Engineer or equivalent with at least 5 years of experience in relevant dsp Laboratory work
- have excellent organization and Planning skills
- have hands-on experience in Purification of biologicals by means of different Chromatography and filtration techniques
- have hands-on experience in using (akta) Chromatography and filtration (tff/dead-end) equipment
- have excellent Communication Skills (fluent in English, written and spoken)
- have excellent knowledge of word, PowerPoint and Excel
- 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
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