Dr. Carolin Witte

Angestellt, Quality Strategy Lead for Data Lifecycle Management, Merck Healthcare KGaA, Darmstadt, Germany

Mainz, Deutschland

Fähigkeiten und Kenntnisse

Scrum
Product Management
Computer System Validation
Projektmanagement
GCLP
GLP
Qualitätsmanagement
Agile Softwareentwicklung
DIN EN ISO 17025
Freude an neuen Herausforderungen
Validation
Klinische Studien
Agile Entwicklung
Digitalization
Softwareentwicklung
Molekulare Biologie
Molekulare Biotechnologie
Bioanalytik
Führungskompetenz
Analytisches Denken
Präsentationsfähigkeit
Koordinationsfähigkeit
Flexibel
Teamplayer
Eigeninitiative

Werdegang

Berufserfahrung von Carolin Witte

  • Bis heute 1 Jahr und 3 Monate, seit Apr. 2023

    Projectmanager Data & Analytics

    Merck KGaA, Darmstadt, Germany

  • Bis heute 9 Monate, seit Okt. 2023

    Quality Strategy Lead for Data Lifecycle Management

    Merck Healthcare KGaA, Darmstadt, Germany

  • 1 Jahr und 6 Monate, Okt. 2021 - März 2023

    Product Owner

    Merck KGaA, Darmstadt, Germany

    • data standards and normalization • Product strategy/roadmap definition • Coordination of business/customer needs, and external business partners/vendors • Communication between technical team and stakeholders • Agile management • requirement definition and prioritization • Define/ensure product quality standards • Drive product release • Resource and budget planning • Project lead for GxP-compliant development (FAIR data, risk-based CSV) • Workflow optimization • Support marketing strategy definition

  • 2 Jahre und 7 Monate, März 2019 - Sep. 2021

    Scientist (Plasma Product Development/Research)

    CSL Behring

    • Process implementation/optimization • SME for business applications and digitalization • gap analysis, root cause analysis, risk and management assessments • Maintain lab management system (DIN ISO 17025) • CSV (GAMP 5) • Representative in study teams • GLP and GCLP compliant work (FDA 21 CFR part 11, OECD No. 17, ICH Q2(R1), USP 1058, and ALCOA+) o bioanalytical testing according to study protocols for clinical trials o data analysis, interpretation, report o assay design, implementation, validation

  • 5 Jahre und 2 Monate, Nov. 2014 - Dez. 2019

    Doctoral Candidate

    Institut für Molekularbiologie und Tumorforschung

  • 8 Monate, Okt. 2013 - Mai 2014

    Student

    University of Cambridge
  • 7 Monate, März 2013 - Sep. 2013

    Graduate Assistant/Tutor

    University of Bielefeld

    coordination, planning, preparing and supporting practical work for students independent work in small projects (cloning, enzyme characterization, growth kinetics)

  • 6 Monate, Okt. 2012 - März 2013

    Intern

    Miltenyi Biotec

  • 10 Monate, Dez. 2011 - Sep. 2012

    Graduate Assistant/Tutor

    University of Bielefeld

    independent work in small projects (cloning, enzyme characterization, growth kinetics) coordination, planning, preparing and supporting practical work for students

  • 3 Monate, Sep. 2011 - Nov. 2011

    Student Assistant

    University of Bielefeld

    autoclave sterilization independent work in small projects (cloning, enzyme characterization, growth kinetics)

Ausbildung von Carolin Witte

  • 5 Jahre und 2 Monate, Nov. 2014 - Dez. 2019

    Experimental Tumor Research and Molecular Biology

    Philipps-Universität Marburg

  • 6 Jahre und 1 Monat, Okt. 2008 - Okt. 2014

    Molecular Biotechnology

    Bielefeld University

    stem cell biology, genetics of eukaryotes, techniques in protein purification, cell-culture technique, applied molecular genetics, proteomics, process engineering, molecular medicine, genetics of prokaryotes

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

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