The role involves preparing instruments and performing critical upstream process operations such as cell expansion and depth filtration in compliance with GMP requirements
Job Summary
The role involves preparing instruments and performing critical upstream process operations such as cell expansion and depth filtration in compliance with GMP requirements.
Candidates will be responsible for drafting and revising essential technical documents including SOPs, MBRs, URS, FAT, and SAT while managing equipment functionality.
An overseas training program is available for qualified candidates to support their professional development within the biopharmaceutical industry.
Matching Summary
Match Score: 85
The role involves preparing instruments and performing critical upstream process operations such as cell expansion and depth filtration in compliance with GMP requirements.
Skills & Requirements
Must-have
GMP compliance in drug substance manufacturing
Cell expansion and cell culture operations
Aseptic procedures and environmental monitoring
SOP, MBR, URS, FAT, SAT documentation
Equipment maintenance and cleaning activities
Nice-to-have
Strong coordination and interpersonal skills
Experience with MES and PCS systems like DeltaV
Proactive and adaptable to dynamic timelines
Ability to work cross-functionally with teams
Key Requirements
Degree in Chemical/Biochemical Engineering or related field
2-4 years of relevant experience in drug substance bioprocess
Familiarity with GMP standards and regulations like 21 CFR Part 11