Jan Smidrkal

Senior Project Manager at Lonza Netherlands, former PharmaCell
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Contact Information
us****@****om
(386) 825-5501
Location
Czechia, CZ

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Credentials

  • Qualified Person
    IPVZ (established by Ministry of Health)
    Sep, 2014
    - Nov, 2024
  • PRINCE - Project Management
    -
    Nov, 2012
    - Nov, 2024

Experience

  • Lonza Netherlands, former PharmaCell
    • Netherlands
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Project Manager
      • Jan 2020 - Present

      - Leading multidisciplinary cross-functional team executing customer manufacturing project during (technology transfer and development, GMP manufacturing) - Cell & Gene Therapy - Leading multidisciplinary cross-functional team executing customer manufacturing project during (technology transfer and development, GMP manufacturing) - Cell & Gene Therapy

  • SOTIO Biotech
    • Czechia
    • Biotechnology Research
    • 100 - 200 Employee
    • Global Project Manager
      • Sep 2017 - Sep 2019

      Management preclinical and clinical Phase I drug development programs (Immuno-oncology) Management of 3 in-licensed programs (semi-virtual) heavily relying on CMO/CRO’s (small molecule, ADC, IL15 fusion protein) Management of crossfunctional teams, working groups and CMO’s/CRO’s focused on: • Non-clinical Development • Clinical Development • Clinical Operations • CMC Development/GMP manufacturing Managing Integrated Project Plan,scope, budget, change management of IL15 fusion protein which succesfully progressed from preclinical stage to Phase I Show less

  • Bohemian Biotech s.r.o.
    • Prague, The Capital, Czech Republic
    • CEO
      • Jan 2016 - Jul 2017

      Industrial Pharmaceutical Biotechnology. Innovative and contract research organization. Industrial Pharmaceutical Biotechnology. Innovative and contract research organization.

  • Lonza
    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Head of Project Management
      • Jul 2014 - Dec 2015

      - Management of the CMO project scopes, timelines, resources and budgets- Leading multidisciplinary cross-functional teams executing customer manufacturing projects during their lifecycle - Management of the Sales&Operations plan of the Kourim site- Preparation of CMO contracts/amendments- Management of Technology Transfers to/from Lonza

    • Program Manager (Project Leader)
      • Jan 2011 - Jun 2014

      - Leading multidisciplinary cross-functional teams executing customer manufacturing projects during their lifecycle (technology development or transfer, scale-up studies, process validation, commercial manufacturing) utilizing microbial fermentation or biotransformation, harvesting and product (proteins, oligomers, small molecules) purification- Managing the CMO project scopes, timelines, resources and budgets for customers ranging from small start-up companies to large pharma corporations - Managing execution of customer project activities necessary for:- - Robust process development/transfer and scale-up- - Successful process validation and submissions to regulatory authorities- - Maximizing value for Lonza and its customers (cost of goods, timeline, milestones)The products my projects were concerned with: 2 large peptides (API/GMP), 1 antibody fragment(API/GMP), 1 midsize antibiotic molecule (API/GMP),1 oligopeptide (34AA- veterinary API),1 small molecule (API/GMP), 3 oligosaccharides (food grade), ca. 5 small molecules (food, cosmetics ingredient, raw material)- Evaluation of new potential customer projects Show less

  • Teva Pharmaceuticals
    • Israel
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • QA Compliance Inspector
      • Aug 2008 - Jan 2011

      - Compliance control of final drug product production adherence to regulatory filings (ANDAs) and cGMP - Leading a multidisciplinary team responsible for Annual Product Reviews of ca. 100 drug products - Responsible for daily quality agenda of products manufactured for US market - Compliance control of final drug product production adherence to regulatory filings (ANDAs) and cGMP - Leading a multidisciplinary team responsible for Annual Product Reviews of ca. 100 drug products - Responsible for daily quality agenda of products manufactured for US market

  • Avid Radiopharmaceuticals
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • R&D Chemist
      • Jun 2007 - Jun 2008

      - Designed, synthesized and characterized potential PET and SPECT imaging agents precursors for early detection of Alzheimer disease using organic synthesis - Developed methods for characterization and labelling - Prepared technical reports for INDAs and Avid IP claims - Designed, synthesized and characterized potential PET and SPECT imaging agents precursors for early detection of Alzheimer disease using organic synthesis - Developed methods for characterization and labelling - Prepared technical reports for INDAs and Avid IP claims

  • University of Pennsylvania
    • United States
    • Higher Education
    • 700 & Above Employee
    • Graduate Research Assistant (Alfred Bader Graduate Fellowship)
      • 2001 - 2007

      PhD Thesis: “Self-Assembled Supramolecular Dendrimers as Porous Protein Mimics”. Advisor: Prof. Virgil Percec - Used a wide variety of synthetic, analytical and biophysical method to create body of work that was published in peer reviewed journals (Nature, J.Am.Chem.Soc., J.Org.Chem, Chem.Eur.J.). PhD Thesis: “Self-Assembled Supramolecular Dendrimers as Porous Protein Mimics”. Advisor: Prof. Virgil Percec - Used a wide variety of synthetic, analytical and biophysical method to create body of work that was published in peer reviewed journals (Nature, J.Am.Chem.Soc., J.Org.Chem, Chem.Eur.J.).

  • Takeda Pharmaceuticals (formerly Nycomed)
    • Switzerland
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • R&D Chemist
      • Jan 1999 - Aug 1999

      - Synthesized and characterized potential X-ray imaging agents - Participated on identifying relevant structural descriptors of hydrophilic iodinated substrates and implemented them into existing multivariate statistical model for design of x-ray contrast agents. - Synthesized and characterized potential X-ray imaging agents - Participated on identifying relevant structural descriptors of hydrophilic iodinated substrates and implemented them into existing multivariate statistical model for design of x-ray contrast agents.

Education

  • University of Pennsylvania
    PhD., Chemistry
    2001 - 2007
  • University of Chemistry and Technology in Prague (UCT Prague)
    MSc., Organic Chemistry
    1994 - 2000

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