MSAT高级总监

南通，中国 | 全职 | Job ID: 11689

Position Summary:

• As a technical lead for Nantong MFG site, lead all the preparation works for the readiness of Pumitamig BLA and introduce any potential project into Nantong successfully.

Your main responsibilities are:

• On the floor to familiarize with the facility, process, equipment, materials, and all necessary knowledge as a priority during the PPQ

• Keep building the Nantong MSAT team and meet the corporate goals

• Lead the PPQ in Nantong

• As a technical lead for the Nantong site's daily manufacturing, deviation, CAPA, change control, validation, and technical protocol/report

• Plan for annual budget and headcount for all technical acticitties and lead hands-on work in the MSAT lab in near future

• As the process owner, after PPQ leads the continuous process improvement and validation

• Ready for being the receiving or sending units for domestic and overseas TT from Nantong

• Cooperate with all relevant departments to move the project forward

• Any other task assigned

What you have to offer:

• Over 12 years of master’s or over 8 years of Ph.D. experience in antibody and recombinant protein development, commercial manufacturing, or MSAT

• Demonstrated solid hands-on experience in development or manufacturing. Downstream background is preferred. Upstream is also available

• Demonstration of the track record of MSAT experience and tech transfer

• Demonstration of experience with deviation, CAPA, change control, gap analysis, and risk assessment

• Experience with process validation and CPV

• Demonstration of leadership in managing complicated projects under different scenarios

• Experience with overseas Tech Transfer is a great plus

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• 联系方式

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• 我们仅接受通过链接在线提交的求职申请。

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• 我们诚挚期待您的加入。