Jian Cui

Senior Vice President, CMC @ Sironax

About

I am a pharmaceutical R&D executive with over 20 years of experience leading global Chemistry, Manufacturing, and Controls (CMC) programs. My career spans both multinational pharma and innovative biotech companies, where I’ve built and led cross-functional teams in process chemistry, GMP manufacturing, regulatory affairs, and drug product development. With a proven record of advancing innovative and generic drug candidates from lab to clinic, I combine deep technical expertise in synthetic organic chemistry with strategic leadership and business acumen. I am passionate about enabling drug discovery and development that improves patient outcomes. Key Strengths: • CMC strategy & execution for IND/NDA submissions • API & drug product development under FDA/NMPA regulations • Building and leading high-performing global R&D teams • Driving partnerships and business growth in pharma and biotech Currently, as Senior Vice President at Sironax, I lead CMC development to support the company’s innovative pipeline. Previously, I served as President of Waterstone Pharmaceuticals and Head of Global CMC Solutions China at BioDuro.

Country

China

City

Beijing

Industry

Biotechnology

Skill

CMC Strategy & Execution, API Development & GMP Manufacturing, Regulatory Affairs (IND/NDA/FDA/NMPA), Project Portfolio Management, R&D Leadership, Innovation Management, Pharma Business Development, Strategic Partnerships & Alliances, Management Of International Teams, Good Manufacturing Practice (GMP), GMP, cGMP, Regulatory Affairs, Investigational New Drug Application (IND), New Drug Application (NDA), CMC development, Process Chemistry, Process Chemistry / Process R&D, Organic Synthesis, Organic Chemistry

Experience

Senior Vice President, CMC

Sironax

2021-8 - Present · 5 yrs 2 mos

Beijing, China

• Lead global CMC strategy and operations to support Sironax’s innovative drug pipeline. • Oversee API and drug product process development, GMP manufacturing, and regulatory submissions under FDA and NMPA guidelines. • Build and manage cross-functional teams across chemistry, formulation, manufacturing, and regulatory functions to accelerate drug development. • Drive partnerships and external collaborations to strengthen clinical development capabilities.

President

Waterstone Pharmaceuticals, Inc.

2012 - 2021 · 9 yrs

Wuhan, Hubei, China

• Founded and led the Waterstone Pharmaceutical Research Institute, and directed end-to-end R&D operations, including CMC, regulatory affairs, and business development. • Responsible for the company's R&D of innovative drugs and generic drugs, as well as the establishment and operation of the polymer drug screening platform. • Successfully advanced multiple drug candidates from preclinical to clinical development, and achieved the approval and market launch of multiple generic drugs.

Head of Global CMC Solutions (GCS) China & Senior Director

BioDuro

2016 - 2018 · 2 yrs

Beijing City, China

• Responsible for leading BioDuro's global CMC solutions business in China. • Provided biopharmaceutical clients and partners with comprehensive, end-to-end fully integrated drug development services to drive the success of innovative and generic drug programs.

Senior VP, R&D

Shanghai SynCores Technologies (Zhejiang Huahai Pharmaceutical Subsidiary)

2011 - 2012 · 1 yr

Shanghai, China

VP of Process R&D

AstaTech, Inc.

2010 - 2011 · 1 yr

Chengdu, Sichuan, China

Principal Scientist

MSD

2009 - 2010 · 1 yr

Rahway, NJ, USA

• Led drug substance outsourcing projects to advance MSD’s global development portfolio. • Managed CMC deliverables as a Pharmaceutical Development Team (PDT) member. • Oversaw API process development and vendor management for clinical supply as a Project Leader in Pharmaceutical Sciences.

Principal Scientist

Schering-Plough Research Institute

2003 - 2009 · 6 yrs

Union, NJ, USA

• Advanced multiple programs from discovery to IND/NDA filing by developing scalable API processes. • Produced APIs under GMP conditions and authored CMC sections for regulatory submissions. • Served as Project Leader in Pharmaceutical Sciences and PDT member, collaborating across cross-functional development teams.

Postdoctoral Fellow

Indiana University Bloomington

2001 - 2003 · 2 yrs

Bloomington, IN, USA

• Conducted total synthesis of complex biologically important natural products. • Developed novel synthetic methodologies for medicinal chemistry applications.