Henry J. Mok, PhD

Technical Project Leader, VP @ Mariana Oncology

About

> Developing next generation CMC professional talents to leave behind a Legacy!> Committed scientific professional with extensive experience in drug substance and product development, managing pharm-dev global operations in CMC, quality and regulatory > Regulatory CMC for eIND, IND, NDA, Post-Approval lifecycle management> Pharmaceuticals development (insource/ outsource) CMC management experience at 8 companies, numerous NCE and Generics

Country

United States

City

Boston

Industry

Biotechnology

Skill

Biotechnology, CMC, FDA, GLP, IND, Technology Transfer, GMP, Validation, Pharmaceutical Industry

Experience

Technical Project Leader, VP

Mariana Oncology

2026-1 - Present · 9 mos

Boston, MA

VP, CMC

Mariana Oncology

2022-7 - 2026-1 · 3 yrs 7 mos

Greater Boston

Head of Regulatory Affairs

Invicro

2021-6 - 2022-7 · 1 yr 2 mos

Boston, Massachusetts, United States

Sr. Director Chemistry, External Manufacturing

Invicro

2018-1 - 2022-7 · 4 yrs 7 mos

Greater Boston Area

Organizational and operational management of external pharma client projects; Manage an effective EM Team of CMC, QA and RA subject matter experts, providing clients with full services support;

Director, CMC Operations

Piramal Group

2013-4 - 2017-12 · 4 yrs 9 mos

Berlin Area, Germany

Associate Director CMC Operations, April 2013-April 2016 Director CMC Operations, April 2016 - Current North America Florbetaben commercial product life cycle management, regulatory affairs, CMC and quality operations since NDA pre-Approval * Regulatory CMC responsibility for North America filings * Quality and Technical Operations, North America commercial manufacturing network Florbetaben, FDA approved since March 2014

Director of Pharmaceutical Sciences

TESARO, Inc.

2011-3 - 2013-3 · 2 yrs 1 mo

Pharmaceutical development, outsource management, CMC regulatory Phase II/III draft and filing. CMC sub-team lead, project team CMC readiness and to enable exploratory IND filing.

Director, Manufacturing/ CMC

Yaupon Therapeutics

2008-8 - 2011-3 · 2 yrs 8 mos

VALCHLOR™ Phase II through NDA readiness for submission. CMC, RA-CMC and QA functions and responsibilities.

Associate Director, Product Development

Molecular Insight Pharmaceuticals

2005-3 - 2008-8 · 3 yrs 6 mos

Senior Scientist March 2005 - January 2007 Associate Director January 2007 - August 2008 Lead small and effective development team on multiple IND Phase I, II, III projects. Responsible for CMC, RA-CMC, outsource management and GMP Quality.