MSAT Functional Leader
2 days ago
Responsibilities
● Responsible for the technology transfer of antibody and conjugation projects. Responsible for the new product introduction evaluation, completion of technology transfer documents according project timeline, including but not limited to Facility/Process Fit, GARA, BOM, PFD, SPL, MBRs, technology transfer report campaign summary report, etc.
● Responsible for the design and implementation of process validation protocol for antibody and conjugation projects, responsible for writing and approving validation reports, and providing necessary on-site production support.
● Create and keep project related documentation updated, include but not limited to: Change control, process flow diagram, manufacturing protocol, master batch record, sampling plan, bill of materials, DV report and RA documents. Coordinate to complete troubleshooting.
● Responsible for overseeing and tracking the GMP production readiness, including but not limited to materials, equipment, etc. Support confirmation of PT list.
● Supporting on-going qualification, periodic review and revalidation of commercial manufacturing projects in the plant.
● Responsible for internal and external communication related to the project. Keep client and CMC team updated on project progress. Communication and coordination with client regarding process and other technology topics. Lead the implementation of project and ensure client requirements discussed during technical transfer are clearly conveyed to production team. Follow up on the progress of project execution.
● Responsible for writing IND/BLA dossiers.
● Support or lead client audit and official inspection, and support client PIP and project related works of customer visits.
Requirements
● Bachelor or above, majoring in life sciences or engineering such as chemical engineering, bioengineering, biology, pharmacy, etc.
● Good communication, teamwork, logical thinking skills, active learning ability and execution ability, with a certain ability to handle pressure.
● Excellent English reading and writing and oral communication skills, meeting organization and document writing ability.
● Strong sense of responsibility, strong willingness and ability to learn, teamwork spirit, positive attitude
Career Development
● Comprehensive in-house training program (E-learning / OJT / Mentorship)
● Dual career development tracks – Professional & Managerial Tracks
● Opportunity for internal job rotation / Cross-BU transfer / Cross-country assignment
● Cross cultural learning
● GMP greenfield start-up experience
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