Ben Machielse Email & Phone Number

Naples, Fl, Us

Amsterdam, Noord-Holland, Nl

Providing consulting services focused on pharmaceutical development, strategy development and support of start-ups.

Gaithersburg, Maryland, Us

Temporary assignment to assist with start-up.

Cambridge, Ma, Us

Gaithersburg, Md, Us

Vtesse, Inc. was a rare disease company dedicated to developing drugs for patients suffering from diseases that are underserved, such Niemann Pick Type C. Vtesse fully enrolled a pivotal clinical study of VTS-270 for NPC, developed new administration methods, optimized the product formulation and conducted pre-clinical discovery and development of other novel drugs for Niemann Pick C and other Lysomal Storage Diseases. In April 2017 Vtesse was acquired by Sucampo Pharmaceuticals.

Vancouver, British Columbia, Ca

Tetragenetics is a biotechnology company focused on the development of an expression platform based on the protozoa Tetrahymena to produce multiple recombinant proteins.

Princeton, Nj, Us

Omthera is a company focused on the development of lipid lowering therapies. In April 2013 the company went public and was sold in July 2013 to Astra Zeneca.- Led all activities related to Product Development, Manufacturing, Supply Chain, Intellectual Property Strategy and Regulatory Affairs.- Directed the submission of the NDA for Epanova.- Managed the development of important IP for Epanova and FDC products. - Developed multiple formulations of FDC products to expand the product profile of Epanova and led the supply chain development achieving significant COGS reductions.- As a member of Omthera's executive team played a key role in Omthera's IPO and the acquisition by AstraZeneca.

Gaithersburg, Maryland, Us

Led worldwide Manufacturing of Therapeutic Antibodies, Small Molecules and Vaccines products. Oversaw QA, QC, GxP Compliance, Validation, Supply Chain, Health & Safety, Government Contracting and Engineering and Facilities in support of organization’s pipeline and commercial products.Member of the Executive Team responsible for the development and execution of the corporate strategy.- Managed and led the development of the first H1N1 vaccine available to US public from clinical development through approval and supply.- Led the design, construction and start up of a new 15,000 liter bioreactor facility- Developed a comprehensive employee development program resulting in high employee engagement and a scalable approach towards ensuring continuous capability development.- Achieved significant reductions in COGS through process improvements, organizational adjustments and streamlining the operations.- Sponsored the development and deployment of the company's first Lean/Six-Sigma strategy.- Sponsored the development of the company's first strategic sourcing platform.

Gaithersburg, Maryland, Us

Directed all aspects of Quality management for MedImmune, including QA, QC, Validation and GxP compliance for all research, development and commercial manufacturing activities.

Pasadena, California, Us

Xencor is company engaged in the development of novel monoclonal antibodies with enhanced biological activity.

Emeryville, California, Us

Led all aspects of Quality management for the company, including QA, QC and Validation.

Us

Rotated through multiple positions of increasing responsibility in manufacturing, process and analytical development, culminating in the position of Director QC; oversaw all aspects of the Quality Control of the late stage and marketed antibody products of Centocor.