Data Reviewer/Associate Scientist

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

Benefits offered by this job

Annual bonus

Medical/dental/vision insurance

Paid PTO & holidays

401K matching

Job summary

KBI Biopharma, a global leader in biopharmaceutical development and manufacturing, seeks a data-focused professional to review analytical method development and testing data for in-process and drug substance samples. You will ensure accuracy, traceability, and regulatory compliance in every report.

Required are a B.S. with 5–7 years’ experience or an M.S. with 4–5 years, plus strong knowledge of cGMP. This role emphasizes data integrity, method understanding, and collaborative problem solving.

Qualifications

• B.S. degree with 5–7 years of related experience, or M.S. with 4–5 years.
• Ability to react to change productively and handle other essential tasks as assigned.
• Experience with biopharmaceutical assays and analytical method development.

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.

Skills

Data analysis

Analytical method development

GMP/compliance

Documentation accuracy

Instrument knowledge

cGMP knowledge

Education

Bachelor's degree

Master's degree

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

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 candidate’s 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.