Pete Vandeberg

About Pete Vandeberg

Broadbased experience in developing new biological products and supporting licensed GMP…

Experience

1. Director, Analytical Development

   Grifols

   Jun 2011 — Present · Raleigh-Durham, NC, US

   As director of analytical development within the R&D organization, I lead all aspects of the method development lifecycle, including development, qualification, validation, transfer and implementation of methods into regulated testing laboratories (GMP, GLP, and GCLP), both internal and external (outsourced) test laboratories. I have experience in the development of a wide range of test methods required to develop and license a biopharmaceutical including physical/chemical methods used assure product quality, potency methods for labeling of dosage, cell based methods such as monocyte activation test (MAT) and histamine release test (HRT), bioanalytical methods used to support non-clinical and clinical studies (i.e. biomarker, PK and immunogenicity), and methods to demonstrate product comparability throughout the product development lifecycle, including advanced characterization methods such as HPLC-MS.I have provided extensive support of the regulatory aspects of product development, including writing CMC sections for regulatory submissions for clinical trials (IND/CTA/IMPD) and for product licensing (BLA/NDA/MA). I have led cross-functional product development teams covering all aspects of pharmaceutical development including preclinical, clinical, process and formulation development. This includes experience working with contract research organizations (CROs) and contract manufacturing organizations (CMOs).

Education

• Saint John's University

  Chemistry, German

  1985 — 1989

• Iowa State University

  PhD, Analytical Chemistry

Skills

• Biochemistry
• Lifesciences
• Purification
• Clinical Development
• Good Laboratory Practice (Glp)
• Lc-Ms
• Lims
• Life Sciences
• Formulation
• Chemistry
• Elisa
• Drug Development
• Standard Operating Procedure (Sop)
• Bioanalysis
• Biopharmaceuticals
• Uv/Vis
• Assay Development
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Sop
• V&V
• Fda
• Validation
• Mass Spectrometry
• Capa
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Laboratory Information Management System (Lims)
• Hplc
• Drug Discovery
• Chromatography
• Protein Chemistry
• Sds-Page
• Immunoassays
• Biotechnology
• Protein Purification
• Research and Development (R&D)
• Glp
• R&D
• Technology Transfer