WuXi AppTec

  • Senior Scientist, Microbiology

    Job Locations CN
    Job ID
    2019-4662
  • Overview

    Company introduction:

    WuXi Biologics is a world-class CMO with the most comprehensive capability and technology platform serving clients globally in the biopharmaceutical and health care industries from discovery to commercialization.  The company is publically listed in Hong Kong, with a market capital of $13 billion.  Our dream is to ensure “every drug can be made and every disease can be treated” to become a reality for both WuXi Biologics and our clients/strategic partners.  The company has sites/offices in China, US, EU, Asia and Israel.  The company currently has 4,000 employees, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.

     

    With the rapid development of the business, WuXi Biologics China is looking for talent at all levels of experience.  We have positions which require from 0 – 20 years of experience and can be from Entry level Scientist to senior Director. These are great opportunities to join our company in China as we continue to build our capacity and technology platform so that “every drug can be made and every disease can be treated”.

     

    Reports to (Title):                             Director of Microbiology

    Location:                                            Wuxi, China

    Direct Reports :                                 Yes

    Department:                                      Commercial & Late Stage QC, WuXi Biologics                                                            

     

    Job Summary: The Senior Scientist or Assistant Director will be leading various technical projects/activities in Microbiology Group of WuXi Biologics.

    Responsibilities

    • Lead or participate microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc.
    • Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs.
    • Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
    • Provide technical guidance/direction to subordinates, as well as evaluate/ introduce new technologies in microbiology area.
    • Assist Microbiology Head to develop micro control strategies, quality enhancement, and operational efficiency improvement.
    • Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
    • Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
    • Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
    • Ability to work in a team environment and independently as required
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
    • Thorough understanding of current Good Manufacturing Practices
    • Other duties as assigned

    Qualifications

    Experience / Education       

    • PhD. with/without post doc experience or MS in Microbiology or related field.
    • Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required.
    • Ability to think critically and demonstrate troubleshooting and problem solving skills
    • Excellent interpersonal skill and verbal and written communication skills
    • Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.

    Knowledge / Skills / Abilities:

    • Excellent Oral & Written communication skills (English and Mandarin)
    • Familiar with requirements of FDA, EMA, and CFDA regulations; ICH and GMP guidelines is a plus

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

     

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