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.

Position 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.

Minimum 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.

Salary: $74,000-$102,300

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidates qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs.