Maarten Friesen

Director Quality Control & Analytical Development at AM-Pharma
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Contact Information
us****@****om
(386) 825-5501
Location
s-Hertogenbosch Area, NL
Languages
  • English Professional working proficiency
  • Dutch Native or bilingual proficiency
  • German Elementary proficiency

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5.0

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Mike Coleman

Maarten is an exceptionally organized and skilled analytical scientist who has made critical contributions to all projects we have worked on together. He is highly knowledgeable not only of the US & EU regulatory requirements for marketing application but also experienced in the necessary requirements to maintain a highly-compliant commercial product after launch. Further, Maarten has the proper interpersonal skills and business acumen to work within the highly complex world of the pharma analytical testing laboratory. He has proven to be capable of organizing and prioritizing challenging testing strategies with great success both with internal and 3rd party resources. Finally, Maarten's knowledge of the science of biologics development has reduced time to commercialization for the programs we have worked on together to great effect!

LinkedIn User

For the last three and a half years I was working in close cooperation with Maarten in his function as study coordinator within a stability project. We were in contact on a daily basis coordinating the work and discussing the project planning. Maarten has a professional but friendly, cooperative and results-oriented approach to work. This made working with Maarten always very nice and pleasant. I really appreciate the lot of fruitful discussions we had and, that even in stressful situations, Maarten managed to focus on the relevant aspects of the process to promote it to success. I really would be happy to work with Maarten again someday.

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Credentials

  • Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass
    GLC Europe
    Mar, 2022
    - Nov, 2024
  • GMP Expert - Pharmaceutical education
    Pharmatech Consultancy & Training
    Mar, 2022
    - Nov, 2024
  • Process Validation for Biotechnological Products MasterClass
    GLC Europe
    Mar, 2022
    - Nov, 2024
  • Intensive individual language training - English
    Language Institute Regina Coeli
    Oct, 2019
    - Nov, 2024
  • ECA - Bioassays and Bioanalytics
    CONCEPT HEIDELBERG GmbH
    Sep, 2018
    - Nov, 2024
  • ECA - Stability Testing for Biological/Biotechnological Drug Substance and Drug Products
    CONCEPT HEIDELBERG GmbH
    Sep, 2018
    - Nov, 2024
  • Situational leadership
    Schouten & Nelissen
    Jan, 2015
    - Nov, 2024
  • Leadership without direct leadership
    Schouten & Nelissen
    Jan, 2014
    - Nov, 2024
  • Project management: project leadership skills
    Schouten & Nelissen
    Jan, 2012
    - Nov, 2024
  • Radiation hygiene level 5B
    Delft University of Technology
    Sep, 2001
    - Nov, 2024

Experience

    • Netherlands
    • Biotechnology
    • 1 - 100 Employee
    • Director Quality Control & Analytical Development
      • Mar 2021 - Present

      QC & AD Lead within CMC Operations at AM-Pharma. Drug Product Lead and point of contact for contract organizations. Write, review and approve CMC documents (e.g. IND, IMPD, QoS, annual updates, briefing book, qualification/verification/validation studies, qualification of critical reagents and reference standards, QbD assessments, (p)CQA assessments). Review and approve batch records and sampling plans for the manufacturing of drug substance/product. Responsible for stability studies and shelf-life extensions of products. Set-up release and stability specifications/acceptance criteria. Collecting and monitoring (e.g. trending, consistency in tests results) of non-GMP and GMP studies. Set-up analytical strategic planning through the different clinical phases and commercialization. Deviation, change and life-cycle management within the projects. Key-person during audits by authorities and GMP audits at contract organizations. Show less

    • Belgium
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Group Lead Analytical Services | Senior Scientist
      • Sep 2020 - Mar 2021

      Group lead within the Analytical Sciences department with main focus on chromatography. CMC and stability expert within the Analytical Sciences department. Analytical lead of several API and nanomedicine projects. Group lead within the Analytical Sciences department with main focus on chromatography. CMC and stability expert within the Analytical Sciences department. Analytical lead of several API and nanomedicine projects.

    • Senior Manager Quality Control
      • Jul 2017 - Sep 2020

      Quality Control Lead within Aduro Biotech Europe and US.Drug Product Lead for monoclonal antibodies projects.Point of contact for internal and external laboratories working on the projects.Writing and reviewing analytical documents (e.g. IND, IMPD, annual reports, validation studies, qualification of critical reagents and reference standards, QbD assessments).Responsible for stability studies and shelf-life extensions of drug substance/product.Set-up release and stability specifications. Collecting and monitoring (e.g. trending, consistency in tests results) of GMP studies within external laboratories.Set-up analytical strategic planning from pre-clinical to commercial.Deviation, change and life-cycle management within the projects.Perform GMP audits at CMO’s and CRO’s.Scientific support for Bio-analytical Development team. Show less

    • Scientist, Analytical Development
      • Jan 2017 - Jul 2017

      Analytical Development Lead within Aduro Biotech Europe.First point of contact for CMOs and CROs working on the projects.Managing stability studies which are according to ICH guideliness.Writing and reviewing analytical protocols and reports (e.g. specifications, annual reports, comparability studies, validation studies, transfer studies, qualification of reference standards, stability studies).Writing and reviewing of initial IND's.Scientific support for Bio-analytical Development team. Show less

    • Netherlands
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Study Coordinator / Scientist
      • Apr 2012 - Dec 2016

      Coordinator for analytical data collection/evaluation and analytical sample distribution. Deputy Analytical Project Lead of a phase III project. Within department Analytical Development and Validation (ADV), section Method Validation Release/Stability Testing. First point of contact for internal and external laboratories working on the project. Writing and reviewing analytical protocols and reports (e.g. annual reports, comparability studies, IND, BLA, validation studies, transfer studies, qualification of reference standards) and support the analytical project lead. Writing and reviewing stability of drug substance/product protocols and reports. Supervision of sample handing and routing within internal and external laboratories (e.g. release and stability testing, validation, support, development). Collecting and monitoring (e.g. trending, consistency in tests results) of GMP studies within internal and external laboratories. Provide support for validation platforms of immunoassays and Experimental Design (DOE). Life-cycle, deviation and change management within the project. Assist for registration of Keytruda® and Ilumya® on multiple markets. Show less

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Internship Flow Cytometry
      • Oct 2011 - Feb 2012

      To get familiar with technique Flow Cytometry and application Infinicyt at Department of Immunology. The internship was started to have a cooperation between CytoTrace BV (later called FagoTrace BV) and Erasmus MC. The intention was to start as an employee at 01 January 2012 at CytoTrace BV but unfortunately CytoTrace BV never started. The scope of CytoTrace: a new biotech company in the life sciences exploring an idea that comprises a breakthrough in the ability to measure human health condition. Our mission is to develop early diagnostics for detection and monitoring disease thereby contributing to the quality of life. Show less

    • Netherlands
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Study Director / Assistant Scientist
      • Apr 2001 - Dec 2011

      Study Director (organizing, supervising and reporting activities) of development and validation studies at Department of Bioanalytics. Quantitative analysis of drug levels for toxico- and pharmacokinetic studies (i.e. bioanalysis). Qualitative analysis of potential unwanted immunogenicity. Responsible for laboratory, laboratory equipment (Luminex Suspension Array System, several pipetting robots, wireless temperature monitoring system and several radioactivity counters), benchmarking and Sample Receiving Officer. Responsible for validation of computerized data and non-data generating systems. Writing and managing of SOPs in English. All activities according to GLP regulations and international guidelines (EMA & FDA). Provided support and training for new employees. Assist for registration of Ganirelx®, Implanon®, Implanon NXT®, Puregon® and Elonva® on multiple markets. Show less

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Lab Technician
      • Sep 1999 - Apr 2001

      Lab Technician at department of Chemical Endocrinology. Quantitative analysis of biomarkers (e.g. Testosteron, DHEAS) in blood samples of patients. Technique: radio-immunoassay (RIA), Micro Enzym Immuno Assay (MEIA) Lab Technician at department of Chemical Endocrinology. Quantitative analysis of biomarkers (e.g. Testosteron, DHEAS) in blood samples of patients. Technique: radio-immunoassay (RIA), Micro Enzym Immuno Assay (MEIA)

Education

  • HU University of Applied Sciences Utrecht (Hogeschool Utrecht)
    BSc, Life Science - Molecular Biochemistry
    2005 - 2008
  • MLO, ROC de Leijgraaf
    -, Clinical Chemistry
    1996 - 2000

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