Manon Van Hoppe

Experience

• 

  Solvay Pharmaceuticals

  Jul 2004 - Dec 2009

  In my function as Analytical Developer I was responsible for the support of laboratory work in France. In the beginning the work was performed form the Netherlands but during my function as Analytical Developer I have been posted in France for six months.In 2007 I have worked for six months in France, as an Analytical Developer. Main task was to transfer analytical method to the new production site of Solvay. The people in the laboratories we trained on the analytical methods before the official transfer took place. In the same time the methods were automized and re-validated. The work was mainly focused one marketed product support, the production site was changed therefore there was the possibility to up-dated the analytical method and up-date the registration dossier.Tasks:- Support laboratory work in France, transfer, develop, validate and perform analytical methods.- Writing protocols and reports of the results of the development, validation and transfer of the analytical methods.- Out sourcing and troubleshooting at contract laboratories.- Writing reports for the registration dossier of marketed products.- Writing stability protocols and reports and start-up stability studies at contract laboraties. Show less In 2007 I have worked for six months in France, as an Analytical Developer. The production site of the marketed products was changed, therefore al the analytical methods needed to be transferred to this site. In the same time the methods were up-dated, automized and re-validated. Main tasks were to transfer the analytical methods to this new site. The people in the laboratories we trained on the analytical methods before the official transfer took place.In this function I have worked independently, and I have adapted myself quickly in this new environment.Tasks:- Support analytical work, transfer, develop, validate and perform analytical methods. Mainly focused on the line extension of marketed pharmaceutical products (answer deficiency letters from authorities).- Out sourcing and troubleshooting at contract laboratories.- Writing reports for the registration dossier. Show less

  • Senior Analytical Developer

    Jan 2009 - Dec 2009

  • Analytical Developer

    Jul 2006 - Dec 2008

  • Analytical developer

    Apr 2007 - Oct 2007

  • Analist B

    Jul 2004 - Jul 2006
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  Abbott Healthcare Products

  Jan 2009 - Dec 2010

  Senior Analytical Developer

  Tasks: Performing practical work using, different techniques such as HPLC, GC, UV-spectrometry and dissolution. Writing development reports, stability reports and reports for the registration dossier, according the ICH guidelines. Transfer and outsourcing of analytical work to contract laboratories and other sites in Europe Automate manual sample preparation with a Tablet Processing Workstation. Automate manual dissolutions with a dissolution robot. The analytical work and planning within pharmaceutical projects and projects within the department. Training of the analysts on new (robotic) equipment. Administration of robotic equipment, like Tablet Processing Workstation and the dissolution robot. Show less

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  Arizona Chemical

  Jan 2011 - Jul 2011

  Technical Specialist Analytical

  Tasks: Provide analytical support for product development, QC-processes and production sites in Europe and the U.S. Responsible for (internal) analytical issues. Coordinate troubleshooting, implementation and development of analytical technologies for support of strategic innovations of current processes. Defines projects with customers and project managers, determine resources and performs laboratory work. Projects vary from troubleshooting for the production processes, support of the European QC departments, development and optimisation of new analytical technologies, investigation towards deviations and the providing of professional knowledge and support for product development. Show less

• 

  Abbott Healthcare Products

  Aug 2011 - Feb 2015

  Scientist

  In my role as an Analytical Scientist I was responsible for the development, validation of analytical methods for processes and release of pharmaceutical products. Different types of equipment are used for the development of the analytical method; such as HPLC, GC, UV-spectrometry and dissolution. The validated methods will be used by different QC laboratories.Tasks: Writing development reports, stability reports and reports for the registration dossier, according the ICH guidelines. Transfer and outsourcing of analytical work to contract laboratories and other sites in Europe Develop automated sample preparation with a Tablet Processing Workstation and transfer the methods to QC laboratories. The analytical work and planning within pharmaceutical projects and projects within the department. Training of the analysts on new (robotic) equipment. Show less

• 

  Mylan EPD

  Mar 2015 - Jul 2017

  Senior Scientist

  In my role as a Senior Scientist I am responsible for the development, validation, transfer and troubleshooting of analytical methods for processes and release of API and pharmaceutical products. Different types of equipment are used for the development of the analytical method; such as HPLC, GC, UV-spectrometry and dissolution. The validated methods will be used by different QC laboratories.The work is performed in cross functional teams which are located globally.Within the group I’m the Dissolution subject matter expert, dissolution is an important tool when changing for example an API supplier in the pharmaceutical process or a manufacturing site of the drug product, it allows you to use a justification for not submitting bioequivalence study.I’m responsible for all the work related to dissolution (development, validation, transfer, troubleshooting). I report to the senior technical manager within the department and I coordinate the work of analysts in the laboratory.I am also responsible for: Writing development reports, validation reports, transfer reports, troubleshooting reports and reports for the registration dossier, according the ICH guidelines. Answer deficiency questions from the authorities. Writing biowaivers and justifications for not submitting bioequivalence studies. Transfer and outsourcing of analytical work to contract laboratories and other sites in Europe. Develop automated dissolutions with a dissolution robot from a manual method. The analytical work and planning within pharmaceutical projects and projects within the department. Training of the analysts on all dissolution equipment. Administration of the dissolution equipment.. Show less

• 

  Abbott

  Aug 2017 - now

  Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.In my role as production manager, I'm responsible for full manufacturing from raw material to the API of the number 1 Brand of Abbott EPD. Leading a team of about 50 Front Line Leaders and and operators. Together with the Franchise Lead and commercial define, support and execute brand strategy, including long range plan ( 5-10 years roadmap). Show less In my role as a Senior Scientist I am responsible for the development, validation, transfer and troubleshooting of analytical methods for processes and release of API and pharmaceutical products. Different types of equipment are used for the development of the analytical method; such as HPLC, GC, UV-spectrometry and dissolution. The work is performed in cross functional teams which are located globally.Within the group I’m the Dissolution subject matter expert, dissolution is an important tool when changing for example an API supplier in the pharmaceutical process or a manufacturing site of the drug product, it allows you to use a justification for not submitting bioequivalence study.I’m responsible for all the work related to dissolution (development, validation, transfer, troubleshooting).I report to the senior technical manager within the department and I coordinate the work of analysts in the laboratory.I am also responsible for: Writing development reports, validation reports, transfer reports, troubleshooting reports and reports for the registration dossier, according the ICH guidelines. Answer deficiency questions from the authorities. Writing biowaivers and justifications for not submitting bioequivalence studies. Transfer and outsourcing of analytical work to contract laboratories and other sites in Europe. Develop automated dissolutions with a dissolution robot from a manual method. The analytical work and planning within pharmaceutical projects and projects within the department. Training of the analysts on all dissolution equipment. Show less

  • Production Manager API

    Jun 2023 - now

  • Junior Product Support Manager

    Feb 2021 - Jun 2023

  • Senior Scientist

    Aug 2017 - Feb 2021