Richard Montes in

Richard Montes

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Sr Director, CMC Statistics at Alnylam Pharmaceuticals
📍 Cambridge, Massachusetts, United States

Richard Montes is the Senior Director of CMC Statistics at Alnylam Pharmaceuticals, bringing over 25 years of experience in pharmaceutical drug development. A PhD graduate from Georgia Institute of Technology, his expertise spans RNAi, biosimilars, and biologics, with a focus on statistical strategies for process optimization and regulatory approval.

He played a key role in influencing the FDAs regulatory framework for demonstrating analytical similarity in biosimilars during his time at Hospira/Pfizer.

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Experience
21 Years
Current Role
Sr Director, CMC Statistics
Job Level
Senior
Location
Cambridge, Massachusetts, United States
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Priorities

Topics Richard cares about

CMC Statistics
His core expertise for over 25 years, focusing on product life cycle, stability trending, and control strategies. He serves on conference committees related to this topic.
Drug Process Optimization
He has published case studies on using Design of Experiments (DOE) and Optimal Design to improve the efficiency and robustness of chemical processes in drug manufacturing.
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Career

Work history

3-2025
Sr Director, CMC Statistics
Alnylam Pharmaceuticals
5-2019 - 2-2025
Director, Statistics - CMC, TOQ
Alnylam Pharmaceuticals
5-2014 - 5-2019
Associate Director, Statistics - Biosimilars Pharmaceutical Sciences
Hospira, a Pfizer company
2-2012 - 4-2014
Manager Quality Statistics
Bristol-Myers Squibb
8-2007 - 2-2012
Sr. Research Statistician (CMC, Non-clinical)
Merck
In the press

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Education
PhD
Georgia Institute of Technology
Applied Statistics
Pennsylvania State University (online)
Social presence
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Behavioral profile

DISC profile (public)

DISC behavioral profile

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