Yang S.

Executive Director & rotational Site Head @ WuXi Biologics

About

A highly credentialed pharmacist specializing in the biopharmaceutical sector, with a proven track record in manufacturing, quality assurance, and CMC management. Experienced in navigating FDA, EMA, and NMPA regulations across prominent biopharmaceutical sites and leading CDMOs in China, the US, Germany, and India. Extensive expertise in biologics, including vaccines and monoclonal antibodies (McAb), encompassing tech transfer, production, GMP system validation, process validation, pre-licensure inspections, routine compliance inspections, quality systems, and preparation of IND/NDA/BLA dossiers. Holds an M.S. in Biochemical Engineering from Zhejiang University, China, and is a certified Project Management Professional (PMP®) by the American Project Management Institute.

Country

China

City

Wuxi

Industry

Biotechnology

Skill

EM, Disposable system, Vaccines, Aseptic connections, Ultra centrifuges, Cell factory, Filling, Lyophilization, GMP, Change Control, Aseptic Processing, CAPA, Quality Assurance, Technology Transfer, Sterilization, Cell Culture, Aseptic Technique, Quality Control, Validation, Manufacturing

Experience

Executive Director & rotational Site Head

WuXi Biologics

2021-9 - Present · 5 yrs

Executive Director, global MFG and rotational Site Head of WuXi Biologics Mashan site (company headquarters). In charge of managing the daily operations of various GMP facilities in terms of budget, P&L, quality, and delivery.

Senior Director, Biomanufacturing

WuXi Biologics

2020-6 - 2022-8 · 2 yrs 3 mos

Wuxi, Jiangsu, China

Director, Drug Products

WuXi Biologics

2018-6 - 2020-6 · 2 yrs 1 mo

Associate Director, Drug Products

WuXi Biologics

2017-5 - 2018-5 · 1 yr 1 mo

QA Program Manager

Abbott

2016-4 - 2017-5 · 1 yr 2 mos

Hangzhou

Oversee several crucial quality systems within the production facility for ophthalmic products. Sterility assurance manager and site QA compliance team leader (audit, training, validation QA, documentation control)

Various Roles

Novartis

2012-9 - 2016-3 · 3 yrs 7 mos

Hangzhou, Zhejiang, China

MSAT Technical Supervisor, shopfloor production manager, new facility start-up manager

Technical Leadership Program

Novartis

2010-4 - 2012-8 · 2 yrs 5 mos

USA

As a Global Management Trainee, he participated in rotations across multiple national manufacturing sites of Novartis Vaccines, obtaining practical, on-the-job training. DS, DP, QA and PM role rotations in Novartis Vaccine US (North Carolina), Germany (Marburg) and India (Ankleshwar) sites.