Senior Director, MSAT (Nantong, JS, CN, 226000)

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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