Allena Ji
Global Head of Diagnostics and Science Affairs, GRD at Chiesi USA, Inc. | Hopkinton, Massachusetts, United States
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Allena Ji serves as the Senior Director of Global Diagnostics & Science Affairs for Global Rare Diseases at Chiesi USA, Inc., where she plays a pivotal role in advancing the company’s commitment to innovative healthcare solutions. With a robust background in bioanalysis and clinical development, Allena specializes in the strategic transfer of clinical trial biomarkers and immunogenicity assays (such as anti-drug antibodies and neutralizing antibodies) to clinical diagnostic laboratories, ensuring compliance with stringent regulatory frameworks including CLIA '88 in the U.S. and ISO certifications in the EU.
In her current role, Allena oversees the meticulous selection of clinical diagnostic laboratories across the U.S. and EU, ensuring that all processes align with the regulatory requirements of US CLIA, EU ISOs, and the EU In Vitro Diagnostic Regulation (IVDR). Her expertise in project management encompasses the entire bioanalytical process, from assay development to CRO monitoring, while maintaining compliance with Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and Good Clinical Practices (GCP).
Allena's leadership is instrumental in the successful transfer of bioanalytical methods from GCLP laboratories to clinical diagnostic settings worldwide, enabling the seamless integration of advanced diagnostic capabilities into clinical practice. Her proficiency in pharmacokinetics, high-performance liquid chromatography (HPLC), and validation and verification (V&V) further enhances her ability to drive projects that support the development of novel therapies for rare diseases. Through her work, Allena Ji not only contributes to the scientific community but also ensures that patients have access to cutting-edge diagnostic tools that can significantly impact their treatment outcomes.
Global Head of Diagnostics and Science Affairs, GRD at Chiesi USA, Inc. in September 2024 to Present
Senior Director of Global Diagnostics & Science Affairs, Global Rare Diseases, Chiesi, USA at Chiesi USA, Inc. in May 2022 to October 2024
Director, Biomarkers and Clinical Bioanalyses at Sanofi in March 2016 to May 2022
Director, Operational Lab, Clinical Laboratory Sciences at Sanofi in January 2013 to March 2016
Director of Bioanalytical Services at WuXi AppTec in April 2010 to January 2013
Associate Director, Bioanaltical R &D, DMPK at Pfizer in March 2005 to April 2010
Principal Research Scientist at Pfizer in January 2003 to March 2005
Senior Research Scientist at Pfizer in September 2000 to January 2003
Associate Director at Kansas City Bioanalytical Services in September 1997 to September 2000
Asisstant Director at Kansas City Bioanalytical Services in September 1995 to September 1997
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Bioanalysis
DMPK
LC-MS
GLP
CRO
Mass Spectrometry
Bioanalytical Chemistry
Validation
HPLC
Analytical Chemistry
Laboratory Automation
Chromatography
Toxicology
UV
SOP
Extraction
IND
Sample Preparation
Sop
Chemistry
R&D
Biomarkers
Information Extraction
Drug Metabolism
Clinical Development
Drug Development
Immunoassays
Assay Development
21 CFR Part 11
Laboratory
Drug Discovery
Clinical Trials
Pharmacokinetics
V&V
Purification
Biopharmaceuticals
Method Development
Protein Chemistry
Biotechnology
FDA
UV/Vis
Standard Operating Procedure (SOP)
CRO Management
Good Laboratory Practice (GLP)
High-Performance Liquid Chromatography (HPLC)
Research and Development (R&D)
Laboratory Skills
Liquid Chromatography-Mass Spectrometry (LC-MS)
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Discover more about Chiesi USA, Inc.What is Allena Ji email address?
Email Allena Ji at [email protected] and [email protected]. This email is the most updated Allena Ji email found in 2026.
What is Allena Ji phone number?
Allena Ji phone number is +16094235913 and +12032140530.
How to contact Allena Ji?
To contact Allena Ji send an email to [email protected] or [email protected]. If you want to call Allena Ji try calling on +16094235913 and +12032140530. (updated on September 13, 2024)
What is Allena Ji net worth?
Allena Ji has an estimated net worth of $150,000 to $249,999
What company does Allena Ji work for?
Allena Ji works for Chiesi USA, Inc.
What is Allena Ji's role at Chiesi USA, Inc.?
Allena Ji is Global Head of Diagnostics and Science Affairs, GRD
What industry does Allena Ji work in?
Allena Ji works in the Pharmaceutical Manufacturing industry.
Allena Ji Email Addresses
Allena Ji Phone Numbers
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