Experience

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  Radboud university nijmegen

  Apr 2013 - Jan 2016

  Research associate

  - Development and preclinical evaluation of imaging pharmaceuticals - Conducting research projects in collaboration with Sanofi (Frankfurt am Main) and Novo Nordisk (Copenhagen)- Presentations in several international congresses

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  Deva holding a.ş.

  Dec 2016 - Apr 2019

  R&d pharmaceutical development specialist

  - Formulation and manufacturing process development, with an understanding on compliance standards and quality requirements (Quality by Design approach)-Responsible for successful technology transfer.-Responsible for process validation.- Data analysis and preparation of technical documents. Regulatory dossier authoring (Module 3 preparation) - Stability follow-up, patent research, evaluation of existing technology to improve efficiency of manufacturing processes. - Project management in accordance with budget plans and deadlines. - Supporting production and marketing department during new product launch. Show less

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  Centrient pharmaceuticals

  May 2019 - Dec 2019

  Global quality assurance officer

  Global Quality Management, Nitrosamine risk evaluations in APIs, Developing and managing KPIs for Quality Management and compliance in different sites, Coordinating risk assessments and projects derived from Regulatory Authorities' requests in global level, Writing/reviewing global SOPs, Participating in continuous improvement of e-Quality Systems, Coordinating cross-functional projects involving R&D, Regulatory Affairs, Sales and Marketing departments.

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  The janssen pharmaceutical companies of johnson & johnson

  Dec 2019 - May 2023

  - Project Leader-- RSV Protein, Vaccine Process Development Team (team consisting of 5 people)- Lead Criticality Analysis to define CPPs and control strategy for DP.- Lead process validation, PPQ execution of RSV protein DP.-Assess any process changes from validation and product quality perspective.-Stakeholder management: interact with QA, RA, Manufacturing, MSAT/Techops and AD teams.- Representing Drug Product Development team during Regulatory Filing preperation/submission stages of new products within the cross-functional teams.- Lead authoring of technical modules of regulatory filings and acting as a Subject Matter Expert in dossier submissions. - Operate as an interface between the company and the (external) manufacturing sites. Maintain a trustful and professional relationship with the external partner.- Participating in defining regulatory strategies and preparation of responses to questions from health authorities during Marketing Authorization Applications.- Set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process.-Responsible for CPV plan for Stage 3a. -Support post approval changes and health authority inspections as process SME. Show less -Project Leader-- RSV PreF Protein Process Development Team (project team of 5 people)- Project Leader--Ebola Vaccines Process Development Team (project team of 3 people)-Representing Drug Product Development team during Marketing Authorisation Application stages of new products within the crossfunctional teams.- Authoring/Preparation of technical modules of regulatory dossiers and acting as a Subject Matter Expert in dossier submissions. - Operate as an interface between the company and the (external) manufacturing sites. Maintain a trustful and professional relationship with the external partner.- Participating in defining regulatory strategies and preparation of responses to questions from health authorities during Marketing Authorisation Applications.- Set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process. Show less -Representing Drug Product Development team during Marketing Authorisation Application stages of new products within the crossfunctional teams.- Authoring/Preparation of technical modules of regulatory dossiers and acting as a Subject Matter Expert in dossier submissions. - Operate as an interface between the company and the (external) manufacturing sites. Maintain a trustful and professional relationship with the external partner.- Participating in defining regulatory strategies and preparation of responses to questions from health authorities during Marketing Authorisation Applications.- Set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process. Show less

  • Scientist Process Development

    Apr 2022 - May 2023

  • Process Development Specialist, Drug Product Development

    Aug 2020 - Apr 2022

  • Senior Applied Process Engineer, Drug Product Development

    Dec 2019 - Aug 2020
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  Bristol myers squibb

  May 2023 - now

  • Manager Manufacturing Science and Technology Process Engineering

    Nov 2023 - now

  • Manager Manufacturing Science and Technology Process Support

    May 2023 - Nov 2023