Not specified; not specified; competitive benefits...
Fully remote
Technical expertise in biologics manufacturing
Experience with ind nda bla submission documents
Knowledge of us fda drug listing processes
The role involves serving as a technical expert for the development, testing, and manufacturing of biologics including mAbs, biosimilars, and CGT
Job Summary
The role involves serving as a technical expert for the development, testing, and manufacturing of biologics including mAbs, biosimilars, and CGT.
Candidates will manage regulatory CMC submission documents for various applications such as INDs, NDAs, and BLAs while facilitating approvals through agency negotiations.
ICON offers a competitive salary, diverse health insurance options, and a global Employee Assistance Programme to support work-life balance.
Matching Summary
The role involves serving as a technical expert for the development, testing, and manufacturing of biologics including mAbs, biosimilars, and CGT.
Salary
Not specified; Not specified; Competitive benefits package included
Skills & Requirements
Must-have
Technical expertise in biologics manufacturing
Experience with IND NDA BLA submission documents
Knowledge of US FDA Drug listing processes
Nice-to-have
Business development support experience
People management capabilities
RAC certification preferred
Key Requirements
Bachelor's degree in life sciences or healthcare field