Cindy Osborn

Cindy Osborn Email and Phone Number

Director of Regulatory Affairs (CMC) @ Pfizer
Cindy Osborn's Location
Silver Spring, Maryland, United States, United States
Cindy Osborn's Contact Details

Cindy Osborn work email

Cindy Osborn personal email

n/a

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About Cindy Osborn

Cindy Osborn is a Director of Regulatory Affairs (CMC) at Pfizer. She possess expertise in cell biology, molecular biology, biochemistry, genetics, western blotting and 10 more skills.

Cindy Osborn's Current Company Details
Pfizer

Pfizer

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Director of Regulatory Affairs (CMC)
Website:
pfizer.com
Cindy Osborn Work Experience Details
  • Pfizer
    Director Of Regulatory Affairs (Cmc)
    Pfizer
    Silver Spring, Md, Us
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  • Pfizer
    Senior Regulatory Manager
    Pfizer Jan 2022
    New York, New York, Us
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  • Fda
    Product Quality Reviewer
    Fda Apr 2019 - Dec 2021
    Silver Spring, Md, Us
    CMC/Product Reviewer for monoclonal antibody and biosimilar in Office of Biotechnology ProductsI review submissions of scientific data from sponsors in Biological License Application (BLA), Investigational New Drug (IND) applications, Annual reports, Protocol Amendments, and labeling for its compliance to safety and efficacy standard according to the FDA guidance and policies to ensure the safety, purity, and potency, of biological products.
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  • Fda
    Cmc Reviewer
    Fda Aug 2015 - Apr 2019
    Silver Spring, Md, Us
    CMC/Product Reviewer for Cell Therapy and Gene Therapy ProductsI review submissions of scientific data from sponsors in Pre-Investigational New Drug packages, Investigational New Drug (IND) applications, Investigational Device Exemption (IDE), Adverse event reports, Annual reports, Protocol Amendments, and labeling for its compliance to safety and efficacy standard according to the FDA guidance and policies to ensure the safety, purity, and potency, of biological products. Research: Lead a regulatory research projects to understand how different manufacturing methods affect the genomic integrity and quality of cultured human induced pluripotent stem cells (iPSCs)
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  • Astrazeneca
    Postdoctoral Researcher
    Astrazeneca Sep 2013 - Jun 2015
    Cambridge, Cambridgeshire, Gb
    I worked in the Cardiac Regeneration area to identify molecules to reprogram cells for treatment of heart disease.
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  • Johns Hopkins University
    Graduate Student
    Johns Hopkins University Aug 2007 - Dec 2013
    Baltimore, Md, Us
    In my doctoral research, I performed cell biology, biochemistry, and genetic studies to characterize epigenetic and transcriptional regulation in Drosophila stem cells’ niche and its differentiation pathway. My characterization of the asymmetric histone inheritance in stem cells contributed to fundamental knowledge in Biology. I also showed for the first time that aminopeptidase played a role in stem cells niche. I proceeded to characterize this enzymes’ substrate using Biochemistry techniques and its function using Cell Biology and Genetics techniques. Lastly, I performed mRNAseq from hand-picked 3-64 cells at specific differentiation stage to systematically investigate transcriptional regulation in spermatogenesis.
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  • Life Technologies
    Intern
    Life Technologies Jul 2013 - Sep 2013
    Waltham, Ma, Us
    I am working with the MCE R&D department to find a more effective nucleic acid delivery system for hard to transfect cells and primary cells
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  • Rockefeller University
    Research Assistant
    Rockefeller University Jul 2005 - Jul 2007
    New York, Ny, Us
    Nucleus acid chemistry
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Cindy Osborn Skills

Cell Biology Molecular Biology Biochemistry Genetics Western Blotting Cell Culture Stem Cells Pcr Protein Chemistry Biology Sequencing Molecular Cloning Research Dna Mammalian Cell Culture

Cindy Osborn Education Details

  • Johns Hopkins University
    Johns Hopkins University
    General
  • The University Of Georgia
    The University Of Georgia
    Biochemistry And Molecular Biology

Frequently Asked Questions about Cindy Osborn

What company does Cindy Osborn work for?

Cindy Osborn works for Pfizer

What is Cindy Osborn's role at the current company?

Cindy Osborn's current role is Director of Regulatory Affairs (CMC).

What is Cindy Osborn's email address?

Cindy Osborn's email address is ci****@****zer.com

What is Cindy Osborn's direct phone number?

Cindy Osborn's direct phone number is +144395*****

What schools did Cindy Osborn attend?

Cindy Osborn attended Johns Hopkins University, The University Of Georgia.

What are some of Cindy Osborn's interests?

Cindy Osborn has interest in Yoga, New Technologies, Hiking.

What skills is Cindy Osborn known for?

Cindy Osborn has skills like Cell Biology, Molecular Biology, Biochemistry, Genetics, Western Blotting, Cell Culture, Stem Cells, Pcr, Protein Chemistry, Biology, Sequencing, Molecular Cloning.

Who are Cindy Osborn's colleagues?

Cindy Osborn's colleagues are Mariam Toure, Maram Rammah Hosni, Ritisha Ande, Martin Wythes, Jessica Andy, Belmerabet Chahira, Dorota Hildebrandt.

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