Mariska Bezemer Email and Phone Number

Ontwikkelen, modificeren, valideren en evalueren van processen en technische apparatuur als procestechnoloog en projectleider.

Professional experienceStarted in 1995 as R&D and QC Technician, after which I successively made a career switch to become a clinical research associate, research engineer, process engineer and Sr. process engineer.2009- present Sr. Process EngineerResponsible as process engineer for several different processes of synthetic bone substitutes (calcium phosphate) as medical devices.• Expert in spray drying and granulation• Specialist in cleanroom packaging (class 7) - Bulk and individual packaging in Tyvek and poly ethylene - Sealing• Validation (by QbD), including: - Risk assessments (e.g. FMEA) - Process capacity calculations / statistics - Proof of Concept modeling• Involved in CAPA procedures• Performing verification studies• Qualification of equipment (IOQ & PQ)• Dossier process expert for Device Master Files (MAF) • Process expert during Audits (clients and authorities) • Senior of the department (supervising interns and colleagues)• Complying to standards - ISO - ICH guidelines - ASTM (FDA) - Pharmacopeias: EP and USP (my latest project is an assessment for elemental impurities in compliance with USP232, risk-based approach)• Writing SOPs• Technical Transfer, including training operators2004-2009 R&D Engineer• Patented (US 9,233,189 B2) an injectable calcium phosphate suspension: - Created the Design History File (DHF) - Monitored the clinical studies - Completed the technical transfer• Development by Quality by Design (QbD)• Team player by changing the company to a quality minded facility.2002-2004 Consultant• Consulting the company about CE application.1999-2002 CRA• Clinical monitor of an international study of a polymer as bone substitute(responsible for the end report).1995-2002 R&D and QC Technician• Developing analytical techniques (in particular for powder characterization)• Writing QC SOPs, complying analytical methods to standards (ISO, USP, ASTM)• Upscaling and developing product lines

• Product Advisor clinical chemical & immunological product line. - Advising and selling to customers - Communication to manufacturers I represented.

• QC Technician bio chemical laboratory- Familiar with general bio chemical techniques: SDS-PAGE Electrophoresis, ELISA, immunoelectrophoresis, DNA isolation, HPLC, GPC, spectrophotometry.

• Technician / Analyst- Clinical chemistry tests- Hematological tests- Immunological tests (specialist in ELISA, RIA)