宏艳康

Associate Director of Operations @ WuXi Biologics

About

复旦大学博士，生物技术制药的研发、注册、质量控制和质量管理和DS GMP生产经验，客户审计和官方审计（NMPA，EMA，FDA）经验，GMP物料管理经验；化药分析研发和IND申报、国家局现场核查经验

Country

China

City

Shanghai

Industry

Pharmaceuticals

Skill

药品生产质量管理规范, SAP, 培训, 气相色谱-质谱联用仪, UHPLC-MS, 质量管理, 质量控制, 分析技能, 项目管理, 生物技术制药

Experience

Associate Director of Operations

WuXi Biologics

2021-10 - Present · 5 yrs

中国上海市浦东新区

助理主任

WuXi Biologics

2020-10 - 2021-10 · 1 yr 1 mo

中国上海市浦东新区

Senior Engineer IV

WuXi Biologics

2019-2 - 2020-10 · 1 yr 9 mos

中国上海

Shanghai GMP Pilant Plant-DS GMP Compliance and Material Management Leader as a lean six sigma project and acquire green belt and yellow belt certifiacte DS GMP compliance and quality events mangment and training Establishment whole workflow in SAP system for material management

Elite Program Rotation 2 Senior Scientist IV

WuXi Biologics

2018-5 - 2019-2 · 10 mos

中国上海

Cell Line Development(CLD) and Protein Science(PS) and cell Banking (CB) Under supervision of Vice President Grasped techniques from transfection、pool and clone selection and stability study New process development for CLD Establishment analytical platform and introduction LIMS for PS Acted as project lead for a pilot scale project Data integrity report and risk assessment for CB EMA Inspection

Elite Program Rotation 1 Senior Scientist IV

WuXi Biologics

2017-7 - 2018-4 · 10 mos

中国上海

Quality Control and Regulator Affairs(QC&RA) Under function head's supervision Estabilishment of project management function Lead cross sites and functions method alignment Act as QC-FL and RA FL

Senior Anlytical Scientist

石药集团药物研究院

2010-7 - 2014-9 · 4 yrs 3 mos

中国河北省石家庄

新药质量标准研究： 1、多尼培南原料和注射用无菌粉末质量标准制定和 CTD 资料的撰写； 2、厄他培南钠原料国家现场核查； 3、利格列汀和阿格列汀原料和片剂质量标准研究； 4、参加了盐酸度洛西汀原料和肠溶胶囊、琥珀酸美托洛尔原料、瑞舒伐他汀钙原料和制剂的质量标准研究和稳定性研究。

Education

Fudan University

药物分析

2014 - 2017 · 3 yrs

Research orientation: metabolomics research in the application of diseases biomarkers discovery based on UHPLC-QTOF and GC-MS technology. Diseases studied including psoriasis 、Cutaneous T Cell Lymphoma、colon cancer.

Fudan University

药物分析

2007 - 2010 · 3 yrs

In vivo Pharmacokinetics study of PEG-IFN and PEG-GH based on ELISA. Four proteins detection based on temperature-and substrate-resolved technology. Aptamer-based techniques for the chemiluminescence detection of thrombin