Andreas Schmidt

Andreas Schmidt Email and Phone Number

CMO Selection and Quality Systems, Director @ Germany
Germany
Andreas Schmidt's Location
Frankfurt Rhine-Main Metropolitan Area, Germany
Andreas Schmidt's Contact Details

Andreas Schmidt personal email

n/a
About Andreas Schmidt

25+ years broad experience in the pharmaceutical industry in the areas laboratory, production, marketing & sales, regulatory and quality. PhD in Organic Chemistry in cooperation with a preclinical research organisation.

Andreas Schmidt's Current Company Details
Merck Healthcare KGaA

Merck Healthcare Kgaa

CMO Selection and Quality Systems, Director
Germany
Andreas Schmidt Work Experience Details
  • Merck Healthcare Kgaa
    Cmo Selection And Quality Systems, Director
    Merck Healthcare Kgaa
    Germany
  • Merck Healthcare Kgaa
    Cmo Selection & Quality Systems, Director
    Merck Healthcare Kgaa Aug 2020 - Present
    Darmstadt, Hesse, Germany
  • Merck Kgaa, Darmstadt, Germany
    Global Project Manager, Director
    Merck Kgaa, Darmstadt, Germany Oct 2016 - Aug 2020
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  • Merck Serono
    Site Quality Head
    Merck Serono Mar 2015 - Sep 2016
    Darmstadt, Germany
    Heading QA and QC with 229 people. Accountable for Quality Systems and release of solids, sterile and non-sterile liquids (12000 batches, 485 Mio blisters, 30 Mio steril ampoules and 25 Mio non-steril units per year) for worldwide supply including U.S.A. Budget: 30 Mio Euro
    View
  • Boehringer Ingelheim Pharma Gmbh & Co. Kg
    Director Systems Quality Assurance
    Boehringer Ingelheim Pharma Gmbh & Co. Kg Jan 2011 - Feb 2015
    Ingelheim, Germany
    Heading a group of 135 people. Accountable for the quality system of three manufacturing sites in Germany. Responsible for the QA-systems CAPA, Deviations, Change Control, SOPs, Training, Inspections, Qualification and Validation. Successful U.S.-FDA Warning Letter remediation.
    View
  • Boehringer Ingelheim Pharma Gmbh & Co. Kg
    Director Api Compliance
    Boehringer Ingelheim Pharma Gmbh & Co. Kg Jan 2010 - Aug 2011
    Heading a group of 54 people with the overall responsibility for all Quality Assurance and Regulatory Affairs topics for all Drug Substances/APIs manufactured at our Ingelheim site. Responsible for the final release and CMC-documentation of these Drug Substances to be placed on the market in about 70 countries for drug products and clinical studies support.
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  • Boehringer Ingelheim Pharma Gmbh & Co. Kg
    Head Of Group Cmc Api
    Boehringer Ingelheim Pharma Gmbh & Co. Kg Jan 2008 - Dec 2009
    Heading a group of 35 people preparing, submitting and managing all authority and customer related questions with respect to Drug Regulatory Affairs in the Drugs Substance/API field of the CMC part of pharmaceutical registration dossiers worldwide.
    View
  • Boehringer Ingelheim Gmbh
    Manager New Business Development
    Boehringer Ingelheim Gmbh Sep 2005 - Dec 2007
    New Business Development in the pharmaceutical industry. Acquisition and Project Management of New Chemical Entity and Drugs Substance projects from industrial customers in U.S.A., U.K., Ireland, Germany, Sweden, France, Switzerland, Japan and Australia. Strategic Business Development in Japan.
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  • Boehringer Ingelheim Pharma Gmbh & Co. Kg
    Acting Production Manager Fine Chemicals
    Boehringer Ingelheim Pharma Gmbh & Co. Kg Feb 2005 - Aug 2005
    Responsible for the continuesly cGMP-compliant production of 45 drug substances in a three-shif-system, including 400 intermediates. Head of 50 employees working in assets of 60 Mio. Euro with a production plant budget of 18 Mio. Euro. Producing controlled substances according the applicable german act.
  • Boehringer Ingelheim Gmbh & Co. Kg
    Plant Manager Api-Production
    Boehringer Ingelheim Gmbh & Co. Kg Jul 2003 - Jan 2005
    Responsible Plant Manager Alkaloide, producing cGMP-compliant drug substances resulting from herbal sources. Head of 25 employees.
  • Boehringer Ingelheim Pharma Gmbh & Co. Kg
    Acting Plant Manager Api
    Boehringer Ingelheim Pharma Gmbh & Co. Kg Jul 2001 - Jun 2003
    Responsible for the logistic team of drug substance production plants with three employees. Acting plant manager of these drug substance production plants.
  • Boehringer Ingelheim Gmbh & Co. Kg
    Head Of Process Optimization Laboratory
    Boehringer Ingelheim Gmbh & Co. Kg Jul 2000 - Jun 2001
    Responsible for the optimization of current chemical production processes, transfer from Process Development to Production Plants and process validation according cGMP with two employees. Project Manager for a laboratory reconstruction project. Acting Head of the analytical In-Process-Control laboratory located in production.
  • Boehringer Ingelheim Gmbh & Co. Kg
    Manager Regulatory Affairs
    Boehringer Ingelheim Gmbh & Co. Kg Oct 1995 - Jun 2000
    Responsible for international registration documentation for drug substances (U.S. Drug Master Files, european Drug Master Files, Certificats of European Pharmacopeia, Manufacturing Descriptions for CMC-sections of pharmaceutical dossiers). Responsible for registrations according european chemical control regulation acts and performing audits according ISO 9001 and Enviromental Health and Safety.

Andreas Schmidt Skills

Change Management Quality Assurance Gmp Chemistry Life Sciences Contract Negotiation Quality Systems Pharmaceuticals Production Marketing And Sales Quality Management Drug Substance Quality System Pharmaceutical Industry Sop Capa Regulatory Affairs Lifesciences Change Control Pharmaceutics V&v Clinical Development Technology Transfer Process Simulation Fda Biotechnology Validation Biopharmaceuticals Organic Chemistry R&d Hplc Manufacturing Analytical Chemistry Glp Union Agreements Standard Operating Procedure Corrective And Preventive Action U.s. Food And Drug Administration

Andreas Schmidt Education Details

Frequently Asked Questions about Andreas Schmidt

What company does Andreas Schmidt work for?

Andreas Schmidt works for Merck Healthcare Kgaa

What is Andreas Schmidt's role at the current company?

Andreas Schmidt's current role is CMO Selection and Quality Systems, Director.

What is Andreas Schmidt's email address?

Andreas Schmidt's email address is an****@****oup.com

What schools did Andreas Schmidt attend?

Andreas Schmidt attended Isb (Institut Für Systemische Beratung), Eq Zert, Steinbeis-Stiftung Für Wirtschaftsförderung, Ulm, Item Communication, Technische Universität Darmstadt, Technische Universität Darmstadt, Adolf-Reichwein-Schule, Heusenstamm.

What skills is Andreas Schmidt known for?

Andreas Schmidt has skills like Change Management, Quality Assurance, Gmp, Chemistry, Life Sciences, Contract Negotiation, Quality Systems, Pharmaceuticals, Production, Marketing And Sales, Quality Management, Drug Substance.

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