SHAN QIAN

Senior Director, head of small molecule DS development @ Simcere Zaiming

About

1. whole-stage CMC expertise adept at DS development (>80 NCEs and 3 drug-linkers) with cost-effective chemistry-innovation & robust process implemented, phases objectives accommodated and compliance guaranteed. 2. cooperative team player in cross-functions and with external partners to expedite the project progress as fast as scientifically practicable; RA and BD support. 3. team building and talents fostering to deliver high performance.

Country

China

City

Pudong

Industry

Pharmaceuticals

Skill

Good Manufacturing Practice (GMP), CMC Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC), Project Management, Chemistry, process research&development, Organic Chemistry, Organic Synthesis

Experience

Senior Director, head of small molecule DS development

Simcere Zaiming

2025-3 - Present · 1 yr 7 mos

1. Full responsibilities for the small molecule DS development including but not limited to phases strategy set-up, objectives harmonization across functions, and resources coordination. 2. Efficient collaboration with external partners to expedite project progress.

Director

Simcere Zaiming

2023-2 - 2025-2 · 2 yrs 1 mo

Nanjing, Jiangsu, CN

Director, PMO

WuXi Chemistry

2021-10 - 2023-1 · 1 yr 4 mos

Shanghai, CN

overall management (planning, execution, monitoring and coordination) of the internal DS development and manufacturing activities (8*PPQs and EP projects) to catch up with the milestones set-up and ensure the on-time deliverables.

Project Leader, CMC

Novartis

2019-1 - 2021-9 · 2 yrs 9 mos

Suzhou, Jiangsu, CN

1. Map and lead DS development at early phase, including but not limited to chemistry innovation, process R&D and manufacturing in pilot plant. 2. As liaison in EPPB to facilitate the project transfer from discovery to development.