Karishma Tejwani

Senior Legal Counsel @BeOne Medicines

Irvine, CA, US

EMAILS

[email protected]

MOBILE NUMBERS

+19•••••••79

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WORK HISTORY

Aug 2023 — Present

Senior Legal Counsel @BeOne Medicines

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EDUCATION

2011 — 2015

Whittier Law School

Juris Doctor (J.D.), Intellectual Property Law

2005 — 2006

UC San Diego

Master of Science (MS), Biology, General

SKILLS

Medical DevicesCapaBiopharmaceuticalsTrackwiseValidationLife SciencesCgmpPatent DraftingGlpBiotechnologyGxpLegal WritingChange Control21 Cfr Part 11GmpQuality AssuranceCleaning ValidationGood Laboratory Practice (Glp)LimsStandard Operating Procedure (Sop)U.s. Title 21 Cfr Part 11 RegulationIntellectual PropertyQuality SystemPharmaceutical IndustrySopFdaLegal ResearchU.s. Food and Drug Administration (Fda)

ABOUT KARISHMA TEJWANI

Experienced in-house counsel with comprehensive understanding of the pharmaceutical industry including drug development through technology transfer and manufacturing scale-up to commercialization. Thorough knowledge of FDA regulations, domestic and international Good Manufacturing Practice regulations. Core competencies include:• Technology Transfer and CMO Management• Pre-clinical, Clinical, Quality, and Supply Agreements • Global IP Strategy• Kaizen/Continuous Improvement• SAPAdmitted to the State Bar of California in 2015 and the U.S. Patent and Trademark Office in 2016.

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