Data Reviewer/Associate Scientist

KBI Biopharma•Boulder, CO

3d•$74,000 - $102,300

About The Position

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: Reviews data associated with development and qualification of biopharmaceutical assay methods and testing of in-process and drug substance/product biopharmaceutical protein samples.

Requirements

B.S. degree and 5-7 years of related experience.
M.S. and 4-5 years of related experience.
Able to react to change productively and handle other essential tasks as assigned.

Responsibilities

Reviews data and reports associated with development and qualification of analytical methods and testing of in-process and drug substance/drug product samples.
Verifies that calculations and documented information are present, complete, and accurate.
Verifies that all analyses are performed per applicable standard operating procedures and test methods, and are in compliance with GMP requirements.
Understands experiments and biopharmaceutical assays used to develop methods and/or test samples.
Maintains and updates knowledge of instrumentation.
Responsible for developing a current understanding of cGMP and other regulatory requirements.
Reacts to change productively and handle other essential tasks as assigned.