Manage
analytical and quality control work at CDMOs and CROs;
Provide input into
the analytical control strategy for clinical stage programs;
Review and approve
documentation such as development and qualification reports;
Independently lead
and develop new experiments, technological or scientific processes;
Design and execute
compatibility studies, method development and characterization assays to
support CMC activities;
Proactively share
skills/knowledge with others to broaden company capabilities;
Take a leadership
role within the lab and the group;
Independently
prepare SOPs and reports, author regulatory documents.
任职资格:
B.S. with 7 or
more years, M.S. with 5 or more years, or PhD in protein biochemistry,
analytical development, formulation development or related fields;
Hands-on experience
with 2 or more of the following techniques required: LC-MS, H/UPLC, SEC-MALS,
icIEF, CE-SDS, SPR, Octet or ELISA techniques;
Experience with
biotherapeutic drug development including method development, transfer and
qualification strongly preferred;
Experience with
formulation development is a plus;
Experience with
compatibility studies is a plus;
Excellent bench
skills and strong documentation skills required;
Strong attention to
detail and generating quality data required; and team player with good
communication skills and ability to work cross functionally required.