Experience

Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Senior Consultant CMC

  • Jul 2012 - Present

  Tasks and responsibilities include advising clients (small pharmaceutical companies as well as „Big Pharma”) on subjects related to CMC activities for small molecule NCE’s and biologicals Accomplishments: -CMC project leader for a compound in pre-clinical and phase I clinical testing. Responsibilities include: advising the client on studies needed for phase I (including specification setting, design of stability studies, validation of analytical methods, choice of formulation for clinical medication, etc), selection of CRO’s and CMO’s for various CMC tasks and monitoring the progress of activities (synthesis of GMP grade API, polymorphism screening, PGI assessment, manufacturing and distribution of phase I clinical material), writing of the IMPD. -Gap analysis for an existing product (manufacturing and analysis) against new upcoming EMA guidance. Advise on activities needed to bring the process and product in compliance with the new guidance documents -Writing of an IMPD for a new recombinant vaccine for phase I/II clinical trials. Gap analysis of missing data and proposals for remediation. Monitoring progress of remediation activities at CRO’s and CMO’s. IMPD was accepted without delays by HSA in Singapore Writing and reviewing of various CMC documents (reports on method validation, stability studies, formulation development, analytical data package for NDA) -Member of the Public Relations Committee Show less



Floris Veterinary Products

• Vught, The Netherlands

• Head of Quality Control

  • Apr 2012 - Jun 2012

  Manager of the Quality Control Department. Tasks and responsibilities include method development, validation, release of raw materials, API and drug products (both products in development and marketed products), stability studies, and trouble shooting and equipment maintenance and control. All activities performed in a GMP environment. Also responsible for authoring of all analytical CMC documentation for regulatory filings. Manager of the Quality Control Department. Tasks and responsibilities include method development, validation, release of raw materials, API and drug products (both products in development and marketed products), stability studies, and trouble shooting and equipment maintenance and control. All activities performed in a GMP environment. Also responsible for authoring of all analytical CMC documentation for regulatory filings.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Analytical Development

  • 2009 - 2011

  Manager / Head of the Department Specifications Development and Analytical Control with full responsibility for all aspects related to human resource management (including training and appraisal), planning (priority setting), investments, budgets, adherence to Health, Safety and Environment (HSE) , regulatory and GMP regulations. Department size: 60+ FTE. Departmental tasks and responsibilities include method development, validation, release of API and drug products for non-clinical and clinical studies, ICH stability studies and method transfers. Also responsible for structure elucidation, solid state screening and form (salt and polymorph) selection studies, (co-) authoring of all CMC documentation for IMP/IND and NDA's and equipment maintenance and control. All activities performed in GMP environment. Accomplishments: Successful reorganization to align with the Schering Plough organization (after the take-over of Organon by Schering Plough in 2009). Excellent GMP and HSE inspection track records. Successful FDA audit on NMR measurement of heparin. Developed and implemented a system to assure that >90% of all deviations and Corrective and Preventive Actions are closed within agreed time lines. Member of the Specifications Development Council Co-leader of a team responsible for the harmonization of strategies in analytical sciences for development within Organon/Schering Plough. Awarded with a Schering Plough Research Institute Excellence Award: Building Alliances. Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive Director

  • 2004 - 2009

  Manager / Head of the Department Analytical Chemistry for Development with full responsibility for all aspects related to human resource management (including training and appraisal), planning (priority setting), investments, budgets, adherence to HSE, regulatory and cGMP regulations. Department size: 60+ FTE. Departmental tasks and responsibilities include all analytical activities for API (both small molecules and biotech compounds): method development, validation, release of API for non-clinical and clinical studies, (ICH) stability studies and method transfers to QC labs in production. Also responsible for structure elucidation, solid state screening and form (salt and polymorph) selection studies, (co-) authoring of all analytical CMC documentation for IMP/IND and NDA's and equipment maintenance and control. All activities performed in GMP environment.Accomplishments:Center of Excellence for Analytical Chemistry within Organon. Change from technique-driven to project-driven organization to improve performanceSuccessful registration of Sugammadex and Asenapine (responsible for API analytical chemistry chapter).Introduction Process Analytical Technologies for API (drying-Mass Spectrometry, reaction monitoring-Infra Red Spectroscopy).Developed and implemented Quick Service for Process Chemistry department.Team Leader for policy development on Potential Genotoxic Impurities.Leader of a Project Team to make recommendations for growing the Biotech Development Organization.2006: laureate of the Hugo van Poelgeest-award for the best alternative to animal experiments in The Netherlands.2008: Recognition Award for contributions made towards full development of corifollitropin alfa (Org 36286). Show less

• Section Leader Drug Product Analytics, Product Development Department

  • 2000 - 2004

  Leading a team (20 FTE) responsible for analytical (bio)chemistry of drug products: method development, validation, release and stability investigations for clinical medication for small molecules and biotech products. (Co-) author of analytical (bio)chemistry CMC documentation for regulatory submissions (IND/IMP, NDA). Responsible for adherence to GMP and HSE. Advises the departmental head on budgeting of resources and investments. Member of project teams for several compounds in development, leader of CMC team for corifollitropin.Accomplishments:Developed and implemented Competence Matrix (balancing training needs for the group and individuals).Contributions (invited speaker/posters) to several conferences on comparability and development of alternatives for bioassays. (Co-) author of scientific, peer reviewed papers on the subject.1999-2001: Member of the Organon Workers Council.2001-2005: Scientific Leader of a project team for the regulatory acceptance of IsoElectric Focusing as alternate method for the in vivo bioassay for recombinant FSH. Approval from EMEA, Australia, Canada, Japan and others in 2003 and US-FDA in 2004. Implementation in the company in 2005.2002-2003: Business Leader of a project team for the interfacing of instruments and Chromatography Data System with LIMS and generation of a Certificate of Analysis directly from LIMS. Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Section Leader Analytical Biochemistry, Department Analytical Chemistry for Development

  • 1997 - 1999

  Leader of a team (15 FTE) responsible for method development, validation, release and stability investigations for new biotech products. (Co-) author of analytical biochemistry CMC documentation for regulatory submissions. Responsible for adherence to GMP and HSE. Advises the departmental head on budgeting of resources and investments. Member of project teams for several compounds in development, leader of CMC team for one compound (corifollitropin, Org 36286, Follicle Stimulating Hormone (FSH) with longer plasma half-life)). Accomplishments: Contributions (invited speaker/posters) to several conferences on comparability and development of alternatives for bioassays. (Co-) author of scientific, peer reviewed papers on the subject. For a complete list see Addenda I and II. 1992-1999: Member of an international project team for the development and world-wide regulatory approval of recombinant Follicle Stimulating Hormone (Org 32489; Puregon/Follistim). 1996-1999: Member of an ECVAM (European Centre for the Validation of Alternative Methods) Task Force on the Quality Control of Hormones. Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Scientist / Group Leader

  • 1994 - 1996

  Leading a team responsible for method development, validation, release and stability investigations for new biotech products. (Co-) author of analytical biochemistry CMC documentation for regulatory submissions. Leading a team responsible for purification and biochemical characterization of gonadotropins with altered pharmacological profiles. Accomplishments: 1992-1999: Member of an international project team for the development and world-wide regulatory approval of recombinant FSH (Org 32489; Puregon/Follistim). 1992-1999: Member of a project team for the selection of recombinant FSH analogues with suitable pharmacokinetic properties (longer and shorter plasma residence time compared to normal FSH). Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist / Group Leader

  • 1990 - 1993

  Purification of (recombinant) proteins for crystallization (e.g. Antithrombin III, Antistasine, Follicle Stimulating Hormone) to aid structure-based drug design. Characterization of monoclonal antibodies against potential tumor-specific antigens; Purification of these antigens. Accomplishments: Co-author of paper in Nature on the first ever successful crystal structure of intact ATIII. Purification of (recombinant) proteins for crystallization (e.g. Antithrombin III, Antistasine, Follicle Stimulating Hormone) to aid structure-based drug design. Characterization of monoclonal antibodies against potential tumor-specific antigens; Purification of these antigens. Accomplishments: Co-author of paper in Nature on the first ever successful crystal structure of intact ATIII.



NIZO

• Netherlands
• Research Services
• 1 - 100 Employee

• Scientist (post doc position)

  • 1988 - 1989

  Scientific research on lantibiotic nisin from Lactobacillus lactis. Accomplishments: New nisin variant identified, purified and characterized. Scientific research on lantibiotic nisin from Lactobacillus lactis. Accomplishments: New nisin variant identified, purified and characterized.



Radboud University

• Netherlands
• Research Services
• 700 & Above Employee

• Ph.D. student

  • 1983 - 1988

  Ph.D. in Mathematics and Natural Sciences, Radboud University, Nijmegen. Degree 1988. Thesis title: Protein interactions and gene expression in the vertebrate eye lens. Promotor: prof. Dr. H. Bloemendal, Co-promotor: prof. Dr. W. de Jong. Ph.D. in Mathematics and Natural Sciences, Radboud University, Nijmegen. Degree 1988. Thesis title: Protein interactions and gene expression in the vertebrate eye lens. Promotor: prof. Dr. H. Bloemendal, Co-promotor: prof. Dr. W. de Jong.