JobMesh

KBI: US - Data Reviewer/Senior Research Associate

KBI Biopharma · Durham, North Carolina, US

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower...

Job description

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This is a Data Reviewer position in Analytical and Formulation Sciences department reporting to Project Leader. Responsibilities: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides. Follow manager’s instructions to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section. Understand principles of the technologies in scope for data review at respective job title level. Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures. Maintain and update knowledge of relevant instrumentation and cGMP standards. Make detail obs...