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Summary

Director Product Development:

With an enthusiastic team, we design and develop genetic diagnostic assays for the clinical market (Research Use Only,  CE/IVD labeled products and custom assays).

My responsibilities focus on :

  • overall management, leading and organization of the Product Development team
  • ensure product development following ISO13485 requirements and CE-IVD Directives
  • ensure communication within and between departments
  • project management within Product Development

Previous experiences:

  • R&D Manager at Multiplicom: Product design and development: expertise in the design and development of genetic MASTR assays, resulting in several commercial RUO and/or CE-IVD marked kits ; Project Management: Implementation of Project Management in a fast growing company. Project manager of several projects at Multiplicom, including European projects and customer requested projects Customer support: assisting in technical matters in customer service
  • PhD student at VIB-UA: Identification of novel mutations and novel genes for Hereditary Sensory (and autonomic) Neuropathies. Study of mutations in cell lines and primary neuronal cells, with fluorescent microscopy, western blots, RNA analysis and mass spectrometry as read out methods. Construction and study of yeast mutants to model genetic deficiencies. The study resulted in several publications in high impact factor journals

Experiences

Current Experience

  • Director Product Development
    Since June 2016
    Management and organization of the development of commercial products and implementation of product improvements

Past Experience

  • Research Manager
    April 2012 --- June 2016

  • Predoctoral Researcher
    March 2006 --- January 2011
    Articles: - Genes for hereditary sensory and autonomic neuropathies: a genotype-phenotype correlation. Rotthier A, et al. Brain. 2009. 132:2699-711. - Mechanisms of disease in hereditary sensory and autonomic neuropathies. Rotthier A, et al. Nat Rev Neurol. 2012. 24:73-85. -Mutations in the SPTLC2 subunit of serine palmitoyltransferase cause hereditary sensory and autonomic neuropathy type I. Rotthier A, et al. Am J Hum Genet. 2010. 8:513-22. -Characterization of two mutations in the SPTLC1 subunit of serine palmitoyltransferase associated with hereditary sensory and autonomic neuropathy type I. Rotthier A, et al. Hum Mutat. 2011-32:E2211-25. -Mutations in FAM134B, encoding a newly identified Golgi protein, cause severe sensory and autonomic neuropathy. Kurth I, Pamminger T, Hennings JC, Soehendra D, Huebner AK, Rotthier A, et al. Nat Genet. 2009.41:1179-81. - Humoral immunodeficiency in congenital insensitivity to pain with anhidrosis. Kilic SS, Ozturk R, Sarisozen B, Rotthier A, et al. Neurogenetics. 2009.10:161-5. - A systematic comparison of all mutations in hereditary sensory neuropathy type I (HSAN I) reveals that the G387A mutation is not disease associated. Hornemann T, Penno A, Richard S, Nicholson G, van Dijk FS, Rotthier A, et al. Neurogenetics. 2009.10:135-43.

  • Scientific coworker
    September 2004 --- February 2006

Knowledge

LinkedIn Assessment :
next generation sequencingProject ManagementProduct designscienceCE-IVD validationSequencingmolecular biologyCell CultureBiotechnologyBioinformaticsCell biologyBiochemistryResearchPCRGeneticsqPCRLifesciencesGenomicsR&DLife SciencesPharmaceutical IndustryScientific WritingProject ManagementPolymerase Chain Reaction (PCR)

Education

  • ir in Agricultural and applied biological sciences from Ghent University in 2004

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Assay Process Developer Clinical Project Manager (CPM) CMC Project Manager Development Manager Managing Director Product Developer Project Manager R&D Director Scientific Advisor
  • Work From Home:
    Yes, 1 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Olen, Belgium

Others

Driving License
  • Yes