>>>Location:Shanghai
【Responsibilities】
Job Summary:
·Responsible for safe, reliable, cost-effective and efficient operation of the Manufacturing, Science and Technology (MSAT) function;
·Responsible to enable excellence in manufacturing by providing manufacturing support to the production organizations that results in safe, high quality and continuously improving production;
Responsible for:
·Technical Product Transfers;
·Investigations management;
·Production process monitoring and improvements;
·Production process validation;
·Technical support for manufacturing;
·Ensure ‘Right to Operate’ through compliance with all applicable GMP, SHE and other global and local regulatory requirements as well as Quality and SHE policies and standards;
·Ensure compliance with Group Code of Conduct;
·As a member of the site leadership team, advises on key and operations related issues, initiatives and strategy for continuous improving the site operations performance;
Main Tasks & Responsibilities:
a). Technical:
·Technical Product Transfers: plan and execute technical product transfers for new and existing products / processes by partnering with internal manufacturing sites and global CDMO partners;
·Investigation management: respond to and proactively identify issues, determine root causes and solve them sustainably; CAPA management;
·Perform routine manufacturingproduction monitoring, ensure process performance is within design;
·Continuous Improvements: drive continuous improvements that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of the production and the MSAT function;
·Support innovation by the introduction of new technologies, manufacturing and business processes and information systems as appropriate to enhance existing operations and strive toward excellence in operations;
·Collaborate closely with global and site functions;
b). Cost Management
·Ensure adequate budgeting for operating costs, headcount and CAPEX;
·Seek for continuous improvements in the department to optimize cost and enhance the department productivity and competitiveness.
【Qualification】
·A Master’s degree in Science (e.g. Biological Science, Biomedical or Chemical Engineering), Preferred: PhD;
·10+ years work experience in the Biologics Manufacturing Science or other related industries;
·5+ years leadership experience and proven track record of effective people management and development;
·Extensive experience of biologics (such as antibody, fusion protein, recombinant protein) manufacturing processtechnical transfer, manufacturing technology, and investigation management;
·Strong communication skills with proficiency in English, both spoken and written;
·Superior problem-solving skills with proven abilities to anticipate issues and recommend effective and efficient solution;
·High cultural awareness and proven ability to work and collaborate with a broad range of cultures;
·Neutral, non-biased analytical and strategic thinking。
>>>Contact Information:
Contact Person:Catrina Yi
Mobile:13551610210
Mail:catrina.yi@isaac-kenneth.com