Data Reviewer/Associate Scientist

KBI Biopharma • Boulder, CO

2d

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.

Benefits

• annual bonus structure for all employees
• medical, dental, and vision coverage
• paid PTO and holidays
• 401K matching with 100% vesting upon hire
• employee recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level