Data Reviewer/Associate Scientist

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 74,000 - 102,300; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

401K matching with 100% vesting upon hire

Employee recognition programs

Job summary

KBI Biopharma, Inc. in Boulder, Colorado is seeking a qualified candidate to review data and ensure compliance with GMP requirements in biopharmaceutical assay methods. The successful candidate will have a B.S. degree with 5-7 years of experience or a M.S. degree with 4-5 years of experience.

The role includes maintaining knowledge of instrumentation and managing documentation to support method development. The position offers comprehensive benefits including medical coverage and an annual bonus structure.

Qualifications

• 5-7 years of related experience with a B.S. degree or 4-5 years with a M.S. degree.
• Ability to manage changing priorities and handle multiple tasks.

Responsibilities

• Review data and reports related to biopharmaceutical assay method development.
• Verify calculations and documented information for accuracy.
• Ensure compliance with GMP requirements.

Skills

Analytical methods

GMP compliance

Data verification

Education

B.S. degree

M.S. degree

Job description

Company Overview

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.

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.
• React to change productively and handle other essential tasks as assigned.

Minimum Requirements

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

Compensation

$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 candidate’s qualifications and experience and may be outside this range.

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.

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.