Ablynx

Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company, with Headquarters in Ghent, Belgium, began operations in 2001 and currently employs over 200 employees. Ablynx is developing a portfolio of Nanobody®-based therapeutic programmes in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Wyeth Pharmaceuticals, Novartis and P&G Pharma.

(Senior) Scientist Team Leader Nanobody® Production

Looking for an (Senior) Scientist Team Leader Nanobody® Production

The CMC upstream processing group (part of the Pharmaceutical Development & Technology Department) is looking for an experienced (Senior) Scientist that will be responsible for:

Process development studies and optimization of the USP platform (non-GMP activities)

Providing CMC support during technical transfer, manufacturing and characterisation

Prepare documentation for pre and post IND/IMPD submissions

Scale-down model development, PAR studies and process validation

Supervision and technical support of the GMP/non-GMP production process of DS/DP for phase I and beyond

You will head and/or collaborate with a team of research associates and scientists and will be responsible for the planning, coordination, follow-up and reporting of assigned project activities. You will be responsible for the research approach and results of an intradepartmental team within the scope of assigned project activities. You will drive the recruitment of team members, training, development and performance management.

You should have hands on experience with state-of-the-art USP equipment such as Sartorius ambr 250 system or other types of benchtop bioreactors and stainless-steel bioreactors including harvest and clarification methods. Have a good knowledge of various analytical methods such as (U)HPLC, SEC, UV- and fluorescence spectroscopy, SDS-PAGE, HCP and endotoxin testing, ELISA… . Knowledge of software packages implemented during USP development such as Sartorius MFCSwin or similar packages for control and data acquisition, LIMS, statistical analysis software such as JMP, SAS, multivariate statistics, DOE and experience with quality by design. You will collaborate in the smooth transfer of the USP technology and accompanying analytical methods from Ablynx development labs to the CMOs. You will be involved in all stages of pharmaceutical development up to life cycle management and critical reagent management.

You should have experience in project management, quality assurance, risk management, process characterization studies, knowledge of regulatory guidelines, GMP & Process Validation. You are experienced in controlling the quality and consistency of biopharmaceutical productions at least at the USP level (microbial and/or mammalian) and assisted in the development of large-scale manufacturing processes. You are experienced in cGMP production processes and in regulatory approvals and adherence with current quality requirements.

You will report about the results and progress to the line manager, project team, project leader and/or external parties in a clear and concise manner. Provides strategic guidance where needed. You will prepare high level reports, summaries, manuscripts and other documents as appropriate.

Profile:

The candidate should:

Hold a degree in Biology, Biotechnology, (Bio)Chemistry, Pharmacology, Bio-engineering or equivalent

Experience as described above and hold 7+ years relevant experience in Biotech/Pharma

Have a proven managerial experience organizational and coordination skills

Have excellent communication skills (fluent in English, written and spoken, knowledge of Dutch is an asset)

Have a sense for initiative, quality, accuracy and detail

Have the ability and desire to work in a fast-paced, dynamic environment

Be a team player, enthusiastic and flexible

You will be part of the USP team existing of ~16 experienced people. You will have the opportunity to work alongside some of the top experts within our field.

Candidates may contact Peter.schotte@ablynx.com

 

Uw sollicitatie zal behandeld worden door het HR departement van Ablynx zelf. Voor alle bijkomende informatie aangaande uw kandidatuur verwijzen we u dan ook vriendelijk door naar het HR departement van Ablynx.


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