- Regulatory Strategies
- CMC
- Manufacturing
- Biologics
- Parenteral Formulations
- Down Stream Processing.
Mr. Goldstein has over 30 years of experience in biologics development including down stream and analytical development. Mr. Goldstein's experience includes leadership roles for the approval of Eli Lilly's cetuximan (ERBITUX), ramucirumab (CYRAMZA), necitumumab (PORTAZZA), and olaratumab (LARTRUVO). Mr. Goldstein was formerly Vice President, Formulation Development, Eli Lilly (formerly ImClone Systems, Incorporated.
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