Director-level CMC & Technical Operations program leader
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Director-level CMC & Technical Operations program leader with 15+ years of experience in FDA-regulated development and commercialization within CDMO/CMO environments and private-label product lines. Leads complex portfolios (15-20 active programs) across OTC/consumer health, dental/oral care, cosmetics, veterinary/animal health, and medical device programs. Accountable for translating finished product Cost of Goods (CoGs) into client-facing R&D, pilot, tech transfer, commercial supply, and packaging-only quotes, incorporating stability, validation, analytical/testing, and packaging scope to enable executable commercial decisions and improve margin/forecast accuracy.
Programs delivered have supported products generating $100M+ in cumulative lifetime sales.
Project Manager - Medical Products Laboratories (MPL) - US Remote
(2017-06)
Scope: 15-20 active programs at a time; 300-500 programs/products and 100-200 commercialization events since 2017; manages three Account Managers; provides weekly executive updates.
Project Manager - KVK-Tech, Inc.
(2016-05 - 2017-05)
Managed 45+ solid-dose and oral solution/suspension programs; coordinated cross-functional execution through development, manufacturing, and submission support; supported accelerated ANDA filing activity.
Project Manager, Logistics - Xcelience, LLC
(2014-07 - 2015-11)
Managed 30 active projects across 17 clients; coordinated materials, documentation, and clinical manufacturing logistics; supported global guideline compliance (FDA/MHRA/JPA/KFDA).
Internal Project Manager - Pharmaceutics International, Inc.
(2010-02 - 2014-07)
Supported billing/logistics operations and portfolio reporting; coordinated manufacturing scheduling and cross-functional release activities.
Assistant Store Manager - Barnes & Noble, Inc.
(2004-11 - 2008-11)
Coursework - Mechanical Engineering - Pennsylvania State University
Coursework - Business - Santa Monica College