Annie Tam

About Annie Tam

Over 15 years experience in a large pharmaceutical company as a Ph.D-organic-chemist-turned- Regulatory-CMC professional. Industry experience as a Regulatory-CMC professional include management of multiple biologics programs, on both early-phase and late-phase, as well as post-approval submissions. Industry experience as a process chemist include small-molecule API\'s, peptides, antibody-drug conjugates (ADC\'s) and antibodies. My breadth of experience is an indication of high versatility, willingness to learn and broad cross-functional knowledge. My goal is to be able to combine my technical acumen and storyboarding skills with my innate ability to distill down the driest of data to communicate to any audience in a clear story.Notable skills- Knowledgeable and experienced in Regulatory-CMC for biologics from pre-FIH to BLA submission, with some experience in post-approval variations and change controls- Organized, meticulous, detailed-oriented and ability to manage multiple complex projects simultaneously- Capable of working under tight timelines in a collaborative, matrix environment- Excellent communication skills with penchant for spinning scientific data/presentations into fascinating stories (accomplishments include 14 publications (7 first-author), a patent, and speaking at global conference)-Technical expertise and real-world experience in establishing an ADC laboratory, developing improved manufacturing processes from small-scale Discovery through large-scale Ph1 and beyond, and Tech Transfer to manufacturers

Experience

1. Associate Director, Global Regulatory Sciences - Cmc

   Bristol Myers Squibb

   Jul 2021 — Present · New Brunswick, NJ, US

   Lead CMC regulatory filings for investigational and post-approval biologics, with experience in preparing initial IND/CTAs, amendments, EU-CTR, BLA, and post-approval variations- Responsible for coordinating and leading CMC submissions with Health Authorities, including responses, briefing books, F2F meetings - Provide regulatory guidance, strategy and perspective in cross-functional project team meetings- Manage multiple programs of various complexities simultaneously

Education

• Regulatory Affairs Professional Society (RAPS)

  Regulatory Affairs Certificate

  2017

• University of Wisconsin-Madison

  Ph.D., Chemistry

• Cornell University

  B.A., Chemistry

Skills

• Pharmaceutical Industry
• Lc-Ms
• Organic Chemistry
• Peptide Synthesis
• R&D
• Bioconjugation
• Formulation
• Chromatography
• Hplc
• Purification
• Process Chemistry
• Nmr
• Mass Spectrometry
• Medicinal Chemistry
• Biochemistry
• Protein Chemistry
• Drug Design
• Drug Discovery
• Organic Synthesis
• Ftir
• Chemistry