Development Scientist Ii, Analytical Development And Clinical Qc
By Alexion Pharmaceuticals,Inc. At , New Haven, Ct
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.
Experience of testing strategy for late-stage program in preparation for BLA filing
Excellent written skill for drafting all the GMP related documents.
Ensure communications occur with stakeholders and partners for all the analytical topics
Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.
Scientist I, Upstream Process Development
By Alexion Pharmaceuticals,Inc. At , New Haven, Ct
Strong ability for people management
Lead small-scale model qualification and process characterization studies
Manage a group of associate scientists to support professional development
Technical knowledge of cell line, upstream, or downstream process development for biologics
Experience in molecular biology, medium and feed development, aseptic techniques and bioreactor operation
Experience using AKTA systems and unicorn software for purification development