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Allena Ji

• Specialties in strategies of transferring clinical trial biomarkers and Immunogenicity assays (ADAs) to clinical diagnostic labs under CLIA... | 74 School Street, Hopkinton, United States

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Allena Ji’s Location 74 School Street, Hopkinton, United States

Allena Ji’s Expertise • Specialties in strategies of transferring clinical trial biomarkers and Immunogenicity assays (ADAs) to clinical diagnostic labs under CLIA 88 regulation in the US and ISO certificates in the EU. Expert in project management of bioanalysis, CRO monitoring, and compliance of GLP, GCLP, and GCP, in bioanalysis, CLIA lab operations for rare disease applications. • Significant function roles in supporting the launches of Eliglustat, Vanglustat, Xenpozyme, Fabrazyme, Lamzede, Elfabrio for Gaucher, AMSD, Fabry, Alfa-mannosidosis rare diseases (enzyme replacement therapy). • Over 20 years of the pharmaceutical industry and CRO work experience in Bioanalysis for supporting Biomarkers/PK and large molecule studies with GLP and GCLP compliance. • American Board Certified for Clinical Chemistry (DABCC), has work experience as CLIA Lab Director, Director of Biomarker of LC/MS/MS labs, and Director of global diagnostics. • Excellent leadership, interpersonal, and communication, presentation skills in collaborating with multiple teams of clinical trial operations, bioanalysis, and CROs business. • A leading author for 40+ publications and a speaker at worldwide conferences. • Invited Speaker for WRIB ( Workshop Recent Issues on Bioanalysis) for last 6 years consecutively

Allena Ji’s Current Industry Chiesi Usa

Allena Ji’s Prior Industry
Kansas City Bioanalytical Services | Pfizer | Wuxi Apptec | Sanofi | Chiesi Usa

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Work Experience

Chiesi Usa

Senior Director of Global Diagnostics & Science Affairs, Global Rare Diseases, Chiesi, USA

Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Sanofi

Director, Biomarkers and Clinical Bioanalyses

Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Sanofi

Director, Operational Lab, Clinical Laboratory Sciences

Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Wuxi Apptec

Director of Bioanalytical Services

Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Pfizer

Associate Director, Bioanaltical R &D, DMPK

Tue Mar 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Pfizer

Principal Research Scientist

Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

Pfizer

Senior Research Scientist

Fri Sep 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)

Kansas City Bioanalytical Services

Associate Director

Mon Sep 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Sep 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)

Kansas City Bioanalytical Services

Asisstant Director

Fri Sep 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

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Allena Ji Email Addresses

[email protected] Email

Allena Ji Phone Number

No phone number available. Phone number

FAQ About Allena Ji

Allena Ji is located at
74 School Street, Hopkinton, United States

Allena Ji is a
• Specialties in strategies of transferring clinical trial biomarkers and Immunogenicity assays (ADAs) to clinical diagnostic labs under CLIA 88 regulation in the US and ISO certificates in the EU. Expert in project management of bioanalysis, CRO monitoring, and compliance of GLP, GCLP, and GCP, in bioanalysis, CLIA lab operations for rare disease applications. • Significant function roles in supporting the launches of Eliglustat, Vanglustat, Xenpozyme, Fabrazyme, Lamzede, Elfabrio for Gaucher, AMSD, Fabry, Alfa-mannosidosis rare diseases (enzyme replacement therapy). • Over 20 years of the pharmaceutical industry and CRO work experience in Bioanalysis for supporting Biomarkers/PK and large molecule studies with GLP and GCLP compliance. • American Board Certified for Clinical Chemistry (DABCC), has work experience as CLIA Lab Director, Director of Biomarker of LC/MS/MS labs, and Director of global diagnostics. • Excellent leadership, interpersonal, and communication, presentation skills in collaborating with multiple teams of clinical trial operations, bioanalysis, and CROs business. • A leading author for 40+ publications and a speaker at worldwide conferences. • Invited Speaker for WRIB ( Workshop Recent Issues on Bioanalysis) for last 6 years consecutively Chiesi Usa

Allena Ji currently works in the
Chiesi Usa

Allena Ji specializes in
• Specialties in strategies of transferring clinical trial biomarkers and Immunogenicity assays (ADAs) to clinical diagnostic labs under CLIA 88 regulation in the US and ISO certificates in the EU. Expert in project management of bioanalysis, CRO monitoring, and compliance of GLP, GCLP, and GCP, in bioanalysis, CLIA lab operations for rare disease applications. • Significant function roles in supporting the launches of Eliglustat, Vanglustat, Xenpozyme, Fabrazyme, Lamzede, Elfabrio for Gaucher, AMSD, Fabry, Alfa-mannosidosis rare diseases (enzyme replacement therapy). • Over 20 years of the pharmaceutical industry and CRO work experience in Bioanalysis for supporting Biomarkers/PK and large molecule studies with GLP and GCLP compliance. • American Board Certified for Clinical Chemistry (DABCC), has work experience as CLIA Lab Director, Director of Biomarker of LC/MS/MS labs, and Director of global diagnostics. • Excellent leadership, interpersonal, and communication, presentation skills in collaborating with multiple teams of clinical trial operations, bioanalysis, and CROs business. • A leading author for 40+ publications and a speaker at worldwide conferences. • Invited Speaker for WRIB ( Workshop Recent Issues on Bioanalysis) for last 6 years consecutively

Allena Ji speaks the following languages:
No languages available.

Allena Ji has prior experience in the following industries:
Sanofi , Sanofi , Wuxi Apptec , Pfizer , Pfizer , Pfizer , Kansas City Bioanalytical Services , Kansas City Bioanalytical Services

Allena Ji has the following professional experience:
Chiesi Usa , Sanofi , Sanofi , Wuxi Apptec , Pfizer , Pfizer , Pfizer , Kansas City Bioanalytical Services , Kansas City Bioanalytical Services .