MSAT高级总监

BioNTech · Zhuhai

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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