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