Emily Alexander

Emily Alexander Email and Phone Number

Global Pathogen Safety Product Ownership & Strategy at CSL @ CSL
king of prussia, pennsylvania, united states
Emily Alexander's Location
Durham, North Carolina, United States, United States
Emily Alexander's Contact Details

Emily Alexander personal email

n/a
About Emily Alexander

R&D expertise in the development of small-scale models and GLP-compliant validation to establish viral safety claims for biotherapeutics. Professional with strong leadership, mentorship, team building, and communication skills. Demonstrated ability to form multi-site collaborations to meet objectives.

Emily Alexander's Current Company Details
CSL

Csl

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Global Pathogen Safety Product Ownership & Strategy at CSL
king of prussia, pennsylvania, united states
Website:
csl.com.au
Employees:
14897
Emily Alexander Work Experience Details
  • Csl
    Head Of Material Safety
    Csl Mar 2024 - Present
    Global
    Responsible for establishing adventitious agent testing strategies for starting and raw materials to ensure virus safety of all CSL products. Lead the Plasma Safety, Testing Strategy, and emerging pathogens Surveillance teams through collaboration with Manufacturing Support, Product Ownership and GPS Laboratories to achieve strategic goals.
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  • Csl
    Senior Manager, Global Pathogen Safety Support
    Csl May 2023 - Mar 2024
    Holly Springs, North Carolina, United States
    Responsible for providing pathogen safety support to the North American Seqirus manufacturing and development sites and providing global support on pathogen safety across the CSL Behring organization.
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  • Grifols
    Associate Director Of Pathogen Safety
    Grifols Jan 2021 - May 2023
    Durham, North Carolina, United States
    Manage the development of small-scale models and the conduct of GLP-compliant studies to establish viral safety claims for plasma-derived biotherapeutics.• Represent Grifols as an expert on pathogen safety• Approve validation protocols and reports authored by study directors • Ensure GLP compliance • Review international guidance and ensure compliance, as applicable• Approve pathogen safety SOPs (document owner)• Manage multiple resources, R&D projects, and timelines• Provide technical and high-level presentations to upper management• Effectively communicate and collaborate with departments across the organization
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  • Grifols
    Sr. Research Scientist Ii (Functional Section Head Of Pathogen Safety Laboratories)
    Grifols May 2019 - Jan 2021
    Durham, North Carolina, United States
    Served the functional role of Section Head of Pathogen Safety laboratories (May 2019 to January 2021). Managed the conduct of GLP-compliant studies to establish viral safety claims on manufactured products.• Managed group leaders and their direct reports• Managed departmental committees • Participated as pathogen safety subject matter expert on R&D project teams• Reviewed validation protocols and reports authored by study directors• Ensured GLP compliance• Ensured compliance with international guidance and industry standards, as applicable• Reviewed pathogen safety SOPs• Managed facility and process audits • Provided technical and high-level presentations to upper management
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  • Grifols
    Sr. Research Scientist Ii
    Grifols Oct 2015 - May 2019
    Durham, North Carolina, United States
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  • Grifols
    Sr. Research Scientist
    Grifols Oct 2009 - Oct 2015
    Durham, North Carolina, United States
    • Performed the roles and responsibilities of a Study Director for GLP-compliant studies to establish viral safety claims on manufactured products• Managed the development of real-time PCR assays for the detection of blood-borne pathogens• Developed and validated new protocols for testing infectious diseases according to cGMP regulations • Developed in vitro medical devices according to 21CFR 820 including Design Control and Risk assessments
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  • Grifols
    Research Scientist
    Grifols Jun 2006 - Oct 2009
    • Managed the development of real-time PCR assays for the detection of blood-borne pathogens• Developed and validated new protocols for testing infectious diseases according to cGMP regulations
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  • Duke University
    Postdoc
    Duke University 2004 - 2006
    Durham, Nc
    Infectious Diseases, Lung Research Biology Group, National Institutes of Environmental Health Sciences (research advisors: Dr. Vance Fowler and Dr. David Schwartz)• Developed a mouse model of Staphylococcus aureus-induced sepsis• Analyzed mouse phenotypes to identify the genetic basis of host susceptibility to S. aureus infection• Genotyped clinical isolates of S. aureus associated with osteomyelitis, endocarditis, soft skin infections and medical implants• Analyzed genetic polymorphisms within S. aureus that may affect the bacteria’s ability to adhere to biomedical devices
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  • University Of Vermont
    Postdoc
    University Of Vermont Sep 2002 - Jun 2004
    Burlington, Vermont
    Microbiology and Molecular Genetics Department (research advisor: Dr. Doug Johnson) - Jul 2003 to Jun 2004• Investigated Candida albicans pathogenesis• Performed cloning and functional assays with novel yeast protein, TOS2• Screened chemical libraries to identify novel molecules that prevent the budded-hyphal transition in yeastImmunobiology, Department of Medicine (research advisor: Dr. Mercedes Rincon) - Aug 2002 to Jul 2003• Evaluated the role of JNK activation in T-cell apoptosis• Maintained and bred transgenic mouse lines
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  • Baxter Healthcare
    Microbiologist
    Baxter Healthcare Jan 1998 - Aug 1998
    North Cove, Nc
    • Supervised a team of technicians• Mastered GLP and cGMP
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Emily Alexander Skills

Elisa Molecular Biology Pcr Glp Microbiology Gmp Qpcr Biotechnology Sds Page Cell Culture Biopharmaceuticals Validation Lifesciences Protein Chemistry Chromatography Purification Assay Development Protein Purification Biochemistry Fda

Emily Alexander Education Details

Frequently Asked Questions about Emily Alexander

What company does Emily Alexander work for?

Emily Alexander works for Csl

What is Emily Alexander's role at the current company?

Emily Alexander's current role is Global Pathogen Safety Product Ownership & Strategy at CSL.

What is Emily Alexander's email address?

Emily Alexander's email address is em****@****ols.com

What schools did Emily Alexander attend?

Emily Alexander attended University Of North Carolina At Charlotte, Unc Charlotte, Unc Charlotte.

What skills is Emily Alexander known for?

Emily Alexander has skills like Elisa, Molecular Biology, Pcr, Glp, Microbiology, Gmp, Qpcr, Biotechnology, Sds Page, Cell Culture, Biopharmaceuticals, Validation.

Who are Emily Alexander's colleagues?

Emily Alexander's colleagues are Sahira Garcia, Tina Fezzoli, Jay Harris, Abhishek Brahma, M Shawkat, Markus Bandschapp, Mike Hart.

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