Wouter Mijs Email & Phone Number

Zwijnaarde, Belgium

• Project leader, responsible for on-time and within-budget delivery of projects.• Project Management for development of processes (upstream - E. coli / Pichia / CHO fermentation, downstream - purification) and analytical methods (SDS-PAGE CBB & WB, BCA, SE-UPLC, RP-UPLC,cIEF, ELISA, …)• Focused on manufacturing of biologicals for Tox studies or Phase I studies (GMP).• Successfully managed projects within the global Eurofins CDMO organization (manufacturingof Drug Substance, fill and finish of Drug Product, labeling and secondary packaging oftherapeutic unit, analytical method validation, stability studies, and QC release tests).

Zwijnaarde, Belgium

• Managed New Product Development projects of immunoassays for in vitro diagnostics (IVD) on the LUMIPULSE® G system in the field of cardiac diseases and neurodegeneration.• Lead the project team of 5 to 7 people (Developers, Technicians).• Presented status updates to the Client (= headquarters in Japan).• Interacted with stakeholders to deliver the project according to Design Control Procedures.• Ensured performance, quality, and compliance of product design based on Risk Assessment.• Achieved successes: launch of two Lumipulse-G assays for use in the diagnosis of Acute Myocardial Infarction (AMI): Lumipulse G hs Troponin I assay, and Lumipulse G Myoglobin assay.

Zwijnaarde, Belgium

• Managed New Product Development projects of DNA multi-parameter IVD assays on the Line Probe Assay (LiPA) platform in the field of infectious diseases.• Lead the project team of 3 to 5 people (Developers, Technicians).• Responsible for Life Cycle Management of nucleic acid (LiPA) and protein based IVD assays (Line Immune Assay, ELISA) for the infectious diseases portfolio of Innogenetics (HPV, HBV, HCV, HIV, HTLV, syphilis, tuberculosis).• Processed Change Control and CAPA projects.• Gave technical and scientific support for Operations, QC, and Customer Support Department.• Achieved successes: Launch of INNO-LiPA HPV extra II, technical improvement of INNO-LIA portfolio

Zwijnaarde, Belgium

• Managed New Product Development projects of DNA multi-parameter IVD assays on the Line Probe Assay (LiPA) platform in the field of infectious diseases.• Lead the project team of 2 to 3 people.• Achieved successes: Launch of INNO-LiPA HBV Multi Drug Resistance, launch of INNO-LiPA HPV extra.• Managed New Product Development projects of Nucleic Acid based IVD multi-parameter microchip arrays (4-MAT) in the field of human genetics (4-MAT HLA DRB, DPB).• Responsible for managing, developing, testing, and maintaining bioinformatics software tools and databases.• Achieved successes: Development of 4-MAT HLA DRB and 4-MAT HLA DPB, establishment of INN4mat development database.

Zwijnaarde, Belgium

• Performed basic research, development, verification and validation of a DNA multi-parameter LightCycler assay to detect and identify clinically relevant Gram positive bacteria, Gram negative bacteria, and fungi in bloodstream infections.• Presented status updates to Client (Roche Molecular Diagnostics in Germany)• Achieved success: Launch of SeptiFast™ LightCycler assay

Zwijnaarde, Belgium

• Worked on prototyping (research) of Nucleic Acid based multi-parameter assays (LiPA) to detect and identify Mycobacterium species, and to detect and identify genetic markers for antibiotic resistance in Mycobacterium tuberculosis.• Achieved success: Launch of INNO-LiPA Mycobacteria, INNO-LiPA Mycobacteria v2, INNO-LiPA Rif.TB. Author of two scientific publications: - Mijs et. al. 2002. Evaluation of a Commercial Line Probe Assay for Identification of Mycobacterium Species from Liquid and Solid Culture. Eur J Clin Microbiol Infect Dis. 21:794-802. - Mijs et. al. 2002. Molecular evidence to support a proposal to reserve the designation Mycobacterium avium subsp. avium for bird-type isolates and 'M. avium subsp. hominissuis' for the human/porcine type of M. avium. Int J Syst Evol Microbiol. 52:1505-1518.