Dr. Nicole Wiedemann

Selbstständig, Pharma Quality Consultant, Consulting
Darmstadt, Germany

Fähigkeiten und Kenntnisse

method (potency/ bioassay
ELISA
qPCR) development & validation & transfer
Quality Assurance
Clinical Trial Management
Product Quality Oversight
Product Quality Management
Product Quality Strategy
QbD
Process Validation
Accelerated Approvals
Late Stage Pharmaceutical Development
Submission and Launch Readiness
PPQ for API and bulk product and finished product
Standard Operating Procedures
Risk mitigation via quality risk-based approaches
Regulatory Requirements
Tech Transfer
Global Cross-Functional Team Leadership
Gate Reviews
Due Diligences
Breakthrough Designation
Contract Manufacturing Organization Management
Audit and Inspection Preparation
Document Review
E2E Product Quality
cGMP
Continued Process Verification
Analytical Method Development and Validation
Project ORBIS
PRIME
RTOR

Werdegang

Berufserfahrung von Nicole Wiedemann

  • Current 2 years and 5 months, since Jan 2024

    Pharma Quality Consultant

    Consulting

  • 8 years and 5 months, Aug 2015 - Dec 2023

    Product Quality Lead

    Merck KGaA, Darmstadt, Germany

  • 2 years and 5 months, Mar 2013 - Jul 2015

    Global Clinical Trial Supply Manager

    Merck KGaA, Darmstadt, Germany

  • 3 years and 2 months, Jan 2010 - Feb 2013

    Laboratory Manager - Bioanalytics NBE - Immunogenicity

    Merck KGaA, Darmstadt, Germany

  • 1 year and 6 months, Jul 2008 - Dec 2009

    Laboratory Manager - Analytical Development Biotech Products - Immunochemistry

    Merck KGaA / Merck Serono

  • 1 year and 6 months, Jul 2008 - Dec 2009

    Laboratory Manager - Immunochemistry

    Merck KGaA, Darmstadt, Germany

  • 2 years and 4 months, Mar 2006 - Jun 2008

    Scientist - Analytical Development Biotech Products - Bioassay Development

    Merck KGaA / Merck Serono

Ausbildung von Nicole Wiedemann

  • 3 years and 10 months, Jun 2002 - Mar 2006

    Immunology, Biochemistry

    German Cancer Research Center (DKFZ), Heidelberg, Germany

    Tumor antigens, Immunochemistry (Luminex, ELISA, SADA, SEREX), Molecular Biology, Proteomics

  • 9 months, Aug 2001 - Apr 2002

    Nutrition

    University of Reading, School of Food Biosciences, UK

    Molecular Biology, Biochemistry, Immunology, Proteomics

  • 5 years and 9 months, Oct 1996 - Jun 2002

    Nutrition

    University of Hohenheim

    Biochemistry, Nutritional Pharmacokinetics and Toxicology

  • 1 year, Oct 1995 - Sep 1996

    Jurisprudence

    Ruprecht Karls University of Heidelberg

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    C1 (Fließend)

  • Italian

    A1-A2 (Grundkenntnisse)

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