Jim Shen
Executive Director, Head of Regulated Bioanalysis & Mass Spectrometry at Bristol Myers Squibb
- Role
- Executive Director, Head of Regulated Bioanalysis, Operations at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Jim Shen
I am a pharmaceutical research executive with thirty years of experience in leading regulated bioanalytical operations within major pharmaceutical companies. I bring extensive expertise in managing GLP/non-GLP laboratories, outsourcing processes, and regulatory interactions. I have successfully submitted multiple bioanalytical assets and have a proven track record of engaging with regulatory agencies globally. As a hands-on manager, I excel in method development, validation, and assay troubleshooting. Recognized as a thought leader in the bioanalytical field, I have a prolific publication record and in-depth knowledge of regulatory guidelines, including GLP, GCP, EMEA, and CFR Part 11. My technical proficiency spans mass spectrometers, automation platforms, and sample preparation techniques, complemented by a deep understanding of project management systems and processes.
Experience
Executive Director, Head of Regulated Bioanalysis, Operations
Oct 2022 — Present · Princeton, NJ, US
Leads the centralized bioanalytical function, overseeing the testing of Pharmacokinetics (PK), ADME biomarkers, and Immunogenicity samples in both preclinical and clinical studies.Manages the operational and financial performance of regulated bioanalysis and operations functions.Provides bioanalytical leadership for Bristol-Myers Squibb (BMS) drug development candidates.Directs regulatory filings and agency interactions for BMS drug candidates.Offers strategic leadership in research direction, scientific expertise, and resource management for regulated bioanalysis groups.
Education
The University of Texas at Austin
Ph.D., Analytical Chemistry
University of Arizona
B.S., Chemistry
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.