RIT Solutions, Inc.
MSAT Principal Scientist - Materials Science
RIT Solutions, Inc., Boston, Massachusetts, us, 02298
MUST HAVE'S;
Performing raw material risk assessments (early phase to late phase).
Material qualification.
Exp with supplier change notifications
MSAT exp is necessary !!
QC raw materials.
Exp with supporting from clinical to commercial w/analytical methods and materials.
• Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and CGT materials. • Previous experience working in a highly matrixed environment.
Extensive experience
with cell and gene and biologics process development and cGMP manufacturing. Experience with cGMP regulations/guidance and regulatory agency inspections. Experience with continuous improvement, proficiency with operational excellence preferred. Experience working with external manufacturing partners (CDMOs), suppliers, and service providers .
• Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and CGT materials. • Previous experience working in a highly matrixed environment.
Extensive experience
with cell and gene and biologics process development and cGMP manufacturing. Experience with cGMP regulations/guidance and regulatory agency inspections. Experience with continuous improvement, proficiency with operational excellence preferred. Experience working with external manufacturing partners (CDMOs), suppliers, and service providers .