跨国医药企业招聘

pharmaron2016

Jobdescription

This isan exciting opportunity to join and contribute to the buildup of a newbiologics manufacturing facility.  This AQposition will lead AD function to support biologics method development and processdevelopment, method transfer and validation as well as trouble-shooting andmanufacturing investigation.  This positionwill play an important role in developing the biologics site to be a top tier manufacturingfacility,

Responsibilities

l  Build up AD department, recruiting and developing its team staff,and setting up lab operation systems.

l  Serve as subject matter expert (SME) and provide technical guidance,instructions and supervision to routine testing and methodology development.

l  Manage work and project plan according to timeline and functionalgoals and objectives

l  Develop group technical capability in analytical tests, andbiological assays in compliance with laboratory operation procedure andapplicable regulations.  

l  Set up suitable laboratory operations practice and rules tocontinuously improve testing

l  Set up high throughput operations to enhance testingefficiency.  

l  Communicate proactively to senior management with regard to projectplan, execution and completion.  

l  Timely apprise senior management of major issue for awareness and discussionand understand the impact to larger organization

l  Innovate new ways of doing testing and create effectivecollaboration with process and manufacturing to make testing high effective andproductive

l  Develop key technical experts within the team and support personnelcareer growth.  Provide coaching andmentoring to junior members and develop their technical and teamworkingcompetence

Qualifications

l  Science or engineering undergraduate degree. Advanced degree (MS orPhD) is a highly desirable.

l  Strong expertise and experience in biologics analytical sciences,with over 10 years of industry experience in biopharmaceutical areas. Must haveprior experience of working with biologics (e.g. Ab).

l  Technical strength in protein analytical methodologies, such asHPLC/UPLC, CE, LC-MS, in-vitro bioassay and ELISA, automaticworkstation, spectrophotometry, endotoxin detection.  

l  Prior experience of leading a team and managing group of people

l  Familiar with biologics development, manufacturing process, criticalcontrol points and Ab critical quality attributes (CQAs)

l  Collaboration, organization, and communication skills are criticalto this role

l  Fluent in English and Chinese